Inflatable Enema Nozzles and TIps - Inflatable enema nozzles are class 2 enema equipment that is formally tracked by the FDA. Inflatable enema nozzles are a separate category altogether as they are considered a serious medical device and often, a controlled device. In the United states there have been a few deaths that resulted from the use of inflatable enema nozzles that contained latex. An FDA notice was released after an investigation into these cases.
Legal Classification: A Class 3 Medical Device.
Manufacturing Requirements: Inflatable Enema nozzles are manufactured by companies that are registered with the FDA. If you wish to manufacture inflatable enema nozzles or import inflatable enema nozzles for sale in the USA you must be prepared for a long legal task.
Retailing Enema Nozzles: Inflatable enema nozzles must be sold in their original packaging. Buying inflatable enema nozzles in bulk and reselling them is illegal as it removes the consumers ability to understand the origin of the device they have purchased. Any company that repackages medical devices in this manner becomes the de facto manufacturer of the products and must assume the responsibility of an equipment manufacturer. If conumers purchase an inflatable enema nozzle or enema tip from a retailer and it is packaged loosely, they should consider returning the device. Product shipped without the manufacturers packaging may not carry any liability insurance and may not have been reviewed by the FDA for safety purposes. Some retailers also remove the packaging from merchandise because it carries a prescription warning. If you receive a device with the note: "To be used under the order of a physician" this is a prescription item and not legal for retail sale online. These items are illegal for retail sale and are illegal to own without a prescription from a licensed physician.
Trademark Notes: In the past, erroneously referred to this type of nozzle as a "B a r d e x" enema nozzle (the spaces are not normally included). This was not only incorrect, but an illegal use of the trademark "B a r d e x" which was registered by the Bard company for the sale of urethral catheters, not rectal devices. Sites that use the term "B a r d e x" in them generally receive a cease and desist letter from the Bard company attorneys, that is why I am putting spaces within the word.
Legal Note: In 2002 Isdera Corp. was sued by the Bard company for the illegal use of the trademark and lost the suit. Bard has been actively defend the mark since that time.