Fact: The only click-style commercial high pressure oxygen regulator specifically manufactured for fishing oxygen systems and sold to fishermen is the Oxygen Edge™ precision dose oxygen regulator, this oxygen regulator is Made in America.
Most click-style medical oxygen regulators are made in China or Mexico, imported to America and sold specifically for patient oxygen therapy in relative clean home care, hospital and medical clinic environments. They are not commercial oxygen regulators. All click-style medical oxygen regulators are manufactured to required FDA specifications for patient use only.
Medical oxygen regulators are not commercial oxygen regulators, they are not made for fisherman use and fisherman abuse in normal marine or freshwater fishing environments on sport fishing boats. RE: ELECTROLYSIS, METAL PITTING DAMAGE AND HIGH PRESSURE OXYGEN SERVICE @ 2200 PSI.
Livewell oxygen systems for fishing use oxygen regulators; “Commercial Grade Oxygen Regulators” and “Medical Grade Oxygen Regulators.” Click-style adjustable pediatric medical oxygen regulators deliver 1/32, 1/16, 1/8, 1/4,1/2, — 4.0 LPM flow rates, 540 CGA or 870 CGA cylinder valve connections. Medical regulators are inexpensive, most have colored anodized aluminum bodies. Some are shinny chrome-nickel alloy plated.
Aluminum body click-style pediatric medical oxygen regulators are manufactured in China under US Patent specification for medical purposes and imported into the USA. They are commonly sold on the internet for $15-$35. These oxygen regulators are cheap to manufacture in China and cheap to purchase in America. Manufacturing and shipping to USA FOB China – less than $3 each. Profit margin is great.
Fishing oxygen systems are often made with pediatric click-style medical regulators Made in China that have been rebranded, relabeled and repackaged then sold new an used as “Commercial Grade” Oxygen Regulators to fishermen without a doctors prescription. A direct violation of FDA and State Health Department’s Medical device regulations and US import regulations for foreign manufactured medical devices. Patient instructions are included in original shipping boxes, the buyer discards patient instruction then re-labels the regulator and sells the regulator over the counter to fishermen. BUYER BEWARE!
Aluminum body adjustable click-style medical oxygen regulators are sold in a variety different colors; blue, green, gold, silver, grey, red, yellow and pink. Come have a shiny chromium alloy plating, like a chrome hub cap. Made in China and Mexico, manufacturing quality control is often lax or totally missing. Before you buy and use any click-style medical oxygen regulator – Consider Safety – YOUR LEGAL RISK, YOUR BOAT INSURANCE RISK and THE FIRE HAZARD of intentionally misusing medical regulators for fishing oxygen systems on boats with pure 100% oxygen.
Two images of the same rebranded green body aluminum pediatric click-style medical oxygen regulator. This regulator is sold as a non medical commercial oxygen regulator used to dispense pure oxygen into an ozone generator in a clean climate controlled environment. Calibrated doses in fractions of liters per minute: 1/31, 1/16, 1/8, 1/4, 1/2… 4.0 LPM flow rates.
The image below is the same pediatric click-style medical oxygen regulator that has been rebranded and sold as a commercial fishing oxygen system regulator. Calibrated doses in fractions of liters per minute: 1/31, 1/16, 1/8, 1/4, 1/2… 4.0 LPM flow rates.
EXPECT SERIOUS ELECTROLYSIS DAMAGE WHEN USED IN FISHING ENVIRONMENTS ON BOATS – SEE WHY ABUSED ALUMINUM BODY CLICK-STYLE PEDIATRIC MEDICAL OXYGEN REGULATORS MAY BE A FIRE AND EXPLOSIVE PRESSURE HAZARD – DANGEROUS
Relabeling this click-style pediatric oxygen regulator “BAIT SYSTEMS” and “NOT FOR HUMAN USE” is deceptive and certainly does not relieve the seller or distributor of any legal liability for selling and distributing mislabeled prescription medical devices as a commercial fishing oxygen regulator. No not be fooled.
The hallmark identification of all pediatric click-style pediatric medical oxygen regulator: All click-style medical oxygen regulators are patent specified, all calibrated to deliver oxygen doses in liters per minute LPM or fractions of LPM and the oxygen dose adjustment is variable.
manufacturer’s original shipping boxes must have the Federal Legend attached to the outside of the box at the initial point of distribution (manufacturer or DME Distributor).
Manufacturer’s written Instructions, Safety Information and Warnings are required by the FDA to be included in each individual shipping box and available to all end user.
OXYGEN FLOW CONTROL REGULATOR – [THESE WRITTEN INSTRUCTION ARE INCLUDED INSIDE EVERY MEDICAL O2 REGULATOR SHIPPING BOX]
“OXYGEN FLOW CONTROL REGULATORS ARE INTENDED FOR ADMINISTRATION OF PURE OXYGEN TO PATIENTS WHO NEED INCREASED OXYGEN LEVELS TO IMPROVE THEIR BREATHING CONDITIONS. “
“THIS UNIT SHOULD ONLY BE USED ON PATIENTS WHO ARE BREATHING; DO NOT USE TO RESUSITATE NON BREATHING PATIENTS. DO NOT USE THIS EQUIPMENT UNLESS YOU HAVE BEEN TRAINED IN THE PROPER USE OR UNDER SUPERVISION OF SOMEONE TRAINED IN ITS USE.”
Regulator connections may be 540 CGA or 870 CGA.
PROFESSIONAL and LEGAL OPINION
Federal Food and Drug Administration, Medical Device Division and Texas Department of State Health Services Health, Medical Device Division: RE: Regulations and opinions affect buying and selling click- style prescription pediatric and adult medical oxygen regulators that are intentionally, mislabeled, relabeled, rebranded and resold as commercial grade fishing oxygen regulators commonly used as a component in homemade livewell and bait tank oxygen systems.
CLICK STYLE PEDIATRIC MEDICAL OXYGEN REGULATORS
FEDERAL LEGEND – “FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN”
This FDA Federal Legend label is affixed on all pediatric and adult medical regulator shipping boxes and also written in all regulator operation instruction enclosed in each shipping box from the manufacturer. ____________________________________________________________________________
Special Fraud Alert
Office of Inspector General
Physician Liability for Certifications in the Provision of Medical Equipment and Supplies
“Physicians should also be aware that they are subject to substantial criminal, civil, and administrative penalties if they sign a certification knowing that the information relating to medical necessity is false, or with reckless disregard as to the truth of the information being submitted.” http://oig.hhs.gov/fraud/docs/alertsandbulletins/dme.htm
VIEW FEDERAL LEGEND LABEL ON PRODUCT INSTRUCTIONS AND SHIPPING BOX
FEDERAL LEGEND – “FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN”
TEXAS DEPARTMENT OF HEALTH – ADVISO
Texas Department of Health opinion regarding medical oxygen regulators sold as bait tank and livewell oxygen systems, October 26, 2001:
“Medical oxygen regulators are considered by both the manufacturers of these devices, state Departments of Health and the Federal Food and Drug Administration to be prescription medical devices.
Under Chapter 483, Health and Safety Code, also known as the “Texas Dangerous Drug Act” the definition of “dangerous drug” includes prescription drugs and prescription devices (Chapter 483.001(2)).
Possession of prescription devices is restricted to those individuals or companies that are authorized to have them (Chapter 483.041).
“A prescription medical device which has had the federal legend label removed or that is missing any labeling (user’s manuals, etc.) which might include the federal legend or similar warnings is considered to be misbranded.
The action of misbranding a medical device or distributing such a device is prohibited and subject to penalties outlined under Chapter 431, Health and Safety Code, also known as the Texas Food, Drug and Cosmetic Act.”
“Advertising involving misbranded devices would need to be evaluated on a case by case basis, but it is addressed in section 431.003, Health and Safety Code, and is subject to the enforcement provisions set forth by the Act.”
“These offenses have civil, administrative and/or criminal penalties afforded to them under the laws and rules. In other words, they can be prosecuted and punished under the laws and rules described.”
Charles P. Davis, Program Director Texas Department of Health Medical Devices Drugs and Medical Devices Division (512) 719-0237 ext 498 Email: mailto:firstname.lastname@example.org ________________________________________________________________________
TEXAS DEPARTMENT OF HEALTH SERVICES
MEDICAL OXYGEN REGULATORS
“I believe any oxygen regulator for medical use would normally be marketed pursuant to 21 Code of Federal Regulations, Part 868.2700 (product code CAN).
It is the only oxygen regulator definition for medical use I’m familiar with.” http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=868.2700
Jeff Mansell, Compliance Officer Drugs and Medical Devices Group Policy, Standards and Quality Assurance Unit Environmental and Consumer Safety Section Division for Regulatory Services Department of State Health Services (512) 834-6755 x 2326 (phone) email: mailto:Jeff.Mansell@dshs.state.tx.us ____________________________________________________________________
IMPORTANT SAFETY ADVISORY FROM MEDICAL OXYGEN REGULATOR MANUFACTURER:
Friday August 3, 2001
To: The Oxygen Edge
From: Manufacturer’s Medical Oxygen Regulator Warranty Division Subject:
Oxygen Warranty Items
This is to outline some of the problems we have seen with medical regulators in bait wells:
1. Medical regulators have printed either on the unit, on the box, and/or in the instructions that they are to be used on the order of a physician. It is not legal to buy these for any other use.
2. Medical regulators are not designed to handle the salt water environment of a fishing vessel.
When I receive medical regulators into my shop for warranty repair, I will not repair them if they have been used in a salt water environment.
For the most part the aluminum and unplated brass components are too corroded to allow disassembly of the unit. In addition, I will not repair an item clearly used in a manner inconsistent with its design.
3. People who are not trained in the safe use of high pressure oxygen administration should NEVER use such equipment.
Oxygen is not safe in the presence of grease, oil, dirt, or any other hydrocarbons — it can cause these items to self ignite, with potentially catastrophic results.
And of course high pressure cylinders with any gas can explode under some circumstances. I have received regulators coming in for warranty repair that were corroded to the extent the knob could no longer turn. The owner of these regulators had sprayed them with WD-40 to get the knob to loosen — I can’t stress enough how dangerous this is. I would not touch such a unit. Kevin Confoy Warranty Division ____________________________________________________________________
Cramer Decker Industries
Questions regarding Pediatric Click-Style Medical Oxygen Regulator manufacture and sales.
1. Does Cramer Decker manufacture and/or sell any click-style pediatric medical high pressure oxygen regulators that are calibrated (0-3 or 0-4 lpm) that are designed for a commercial (non medical) applications and sold to deliver Commercial Welding Oxygen specifically at (1/32, 1/16, 1/8, 1/4, 1/2 – 3.0 or 4.0 lpm), not designed and manufactured for human use or USP Oxygen administration….
Answer: “No, we do not offer click style regulators for COMMERICIAL use. The regulators we have are made for home medical use.”
Philip Le Customer Service Representative Cramer Decker Industries 1641 E. St. Andrew Place Santa Ana, CA 92705 (800) 752-4579 Email: mailto:email@example.com __________________________________________________________________________
MEDICAL OXYGEN REGULATORS – FEDERAL LEGEND LABEL
All medical oxygen regulator manufacturers are required by Federal Law to attach a FDA Federal Legend to oxygen regulator shipping boxes before the regulator is shipped to a distributor or Durable Medical Equipment Supplier (DME).
The Federal Legend must also be on the operating instructions included inside the shipping box It is a violation of Federal Law to remove the Federal Legend from the box or remove the original operating instructions from the shipping box prior to final sale of the regulator.
When the Federal Legend is removed prior to final sale, the regulator is considered misbranded, relabeled and repackaged for uses other than intended by the manufacturer.
Pediatric click-style medical oxygen regulators are controlled medical devices that require a Physician’s Order (written prescription) for purchase and possession. Buyer Beware!
Medical oxygen regulators are controlled medical devices, they may be dangerous when used in hostile environments other than hospitals, clinics and emergency medicine.
Medical oxygen regulators are not made for nor intended for use in harsh fishing environments by fishermen to oxygenate livewells.
The 2 images at the top of this web page are examples of misbranded, relabeled and repackaged prescription click-style pediatric medical regulators delivery doses calibrated in fractions of liters per minute (LPM), sold illegally over the counter as commercial “bait tank oxygen systems regulators.”
Click-style pediatric medical oxygen regulators: In order to sell medical oxygen regulators as fish O2 regulators salesmen often define medical regulators by saying his click-style fishing oxygen regulator is not medical oxygen device because it uses commercial welding oxygen, not prescription medical Oxygen USP or the regulator connects to a 540 CGA oxygen cylinder valve, not a 870 CGA Post Valve or “NOT FOR HUMAN USE” is embossed on the aluminum regulator body or is stated on the attached label.
Some DME Supply stores sell prescription medical oxygen regulators over the counter to fishermen for cash, no doctor’s prescription necessary for purchase.
Be on guard for the slick salesmen that defines and justifies selling misbranded, relabeled click-style pediatric medical oxygen regulator as a “commercial fishing oxygen regulators as fishing oxygen regulators that uses welding oxygen and connects to a 540 CGA cylinder valve.
Or, this click style oxygen regulator has “NOT FOR HUMAN USE” stamped on the regulator body.
The slick salesmen’s definitions are meaningless sales gimmicks used to sell click-style medical oxygen regulators often MADE IN CHINA and imported into the USA.
FACT: Companies that have click-style medical oxygen regulators manufactured in China are considered by the FDA as OEM and must attach the Federal Legend; it must be clearly visible on the outside of the product box and printed on the enclosed operating instructions before resale.
Medical oxygen regulator manufacturer ship click-style oxygen regulatosr to a DME company for resale, the Federal Legend is always attached to the shipping box and the written instruction inside the shipping box.
FACT: Federal Legend labeling is regulated by the FDA. Always ask the seller to show you the original shipping box and the original operating instructions before purchase.
If the seller refuses or makes an excuse not to show you the original shipping box, that is a “red-flag” warning that often indicates potential deceptive sales of an illegal prescription medical device.
Buyer Beware, that mistake could cancel your boat insurance and cause you unnecessary legal risk in case of accident.
The difference between a prescription pediatric click-style medical oxygen regulator and a commercial oxygen regulator is not defined by whether the regulator dispenses medical “OXYGEN USP” or commercial welding oxygen gas or what oxygen cylinder valve the regulator connects to.
HOW ARE MEDICAL OXYGEN REGULATORS DEFINED AND IDENTIFIED BY A FISHERMAN?
Click style pediatric medical oxygen regulators are always calibrated and deliver oxygen in liters per minute (LPM) and fractions of liters per minute (1/32, 1/16, ¼, ½, ¾ 1.0… LPM).
Dose range is usually 0-4 LPM.
FACT: The regulator dose calibration (LPM) defines a high pressure oxygen regulator as a prescription medical device.
Many aluminum oxygen regulatorbrands have colored anodized aluminum bodies (green, blue, red, etc.) or a shinny chrome finish, shinny like a car bumper.
Nickel plated regulators are not shinny like chrome, they look dull like a tarnished old 1943 Buffalo Nickel. The Oxygen Edge™ regulator is nickel plated.
All medical oxygen regulators sold by all regulator manufacturers are shipped with the FEDERAL LEDGEND label fixed to the outside of the shipping box and also in the written operation instructions inside the shipping box.
Removal of the FEDERAL LEGEND and resale is illegal. The regulator is considered misbranded when/if the Federal Legend is removed from the shipping box or operation instructions before the final sale. ___________________________________________________________________________
MISLABELED CLICK STYLE PEDIATRIC MEDICAL OXYGEN REGULATORS are/were SOLD HERE
http://www.pro-o2.com/ BAAD Marine Supply18300 E. Hwy 6 between Alvin and Santa Fe, TX
http://www.inmonrespiratory.com/ Inman Respiratory Services, Corpus Christi, TX
http://www.keepalive.net/oxygen/ KeepAlive, Tarpon Springs, FL
http://www.fishingpharmacy.com/pure-oxygen-equip-c-114.html?zenid=e51ded66b7967e61836c203398b164c7 Fishing Pharmacy, 3197 War Hill Park Rd.. Dawsonville, GA
http://www.hammondsfishing.net/ Hammonds Fishing Supply, Cumming, GA
American Bolt & Gasket, DBA Oxygen Bait Saver ™, 18533 Fm 365 Rd., Beaumont, TX 77705, Jefferson County, TX
J & J Tackle Town, Rockport, TX Custom Oxygen Systems, San Antonio, TX