AM 100p Anesthesia Flush Plug
A device with a handle used to plug the end of an anesthesia circuit/breathing circuit at two possible locations: the Y-piece or the gas sampling elbow. The temporary plugging of the…
A device with a handle used to plug the end of an anesthesia circuit/breathing circuit at two possible locations: the Y-piece or the gas sampling elbow. The temporary plugging of the anesthesia breathing circuit allows anesthetic gases to be flushed from the anesthesia machine through the WAG (waste anesthetic gas) scavenging line by way of continuous oxygen/air flow rate over a set amount of time, or by activating the flush valve and applying positive bag pressure in repeated succession. This practice reduces the amount of anesthetic gas released into the operating room and thus reduces harmful gas exposure to operating room personnel and premature anesthetic gas exposure to patients during preoxygenation or mask induction. There is no patient contact as the plug must be removed before the breathing circuit can be attached to a mask, endo/naso-tracheal tube, or any other breathing device.
Who Else Makes It
Concentrated in Zhejiang (18), Guangdong (18), Jiangsu (5). 18 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Hangzhou Formed Medical Devices Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
Showing 12 of 55. All 55 manufacturers in China registered for Circuit, Breathing (W Connector, Adaptor, Y Piece)
Record
| Listed by | Instrumentation Industries, Incorporated, United States |
|---|---|
| FDA product code | CAI |
| Device type | Circuit, Breathing (W Connector, Adaptor, Y Piece) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5240 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-07-27 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant, Ethylene Oxide |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Ziplock bag of 50, ziplock bag of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AM 100P | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 3,457 |
| Vital Signs™ | Airlife, Inc. | 1,018 |
| Hudson RCI | Teleflex Medical LLC | 176 |
| Vital Signs™ | AirLife Finland Oy | 143 |
| Universal F2®ANESTHESIA Breathing Circuit | King Systems Corporation. | 133 |
| Universal FLEX2®BREATHING Circuit | King Systems Corporation. | 123 |
| Adult Ultra Flex®anesthesia Breathing Circuit | King Systems Corporation. | 111 |
| Portex | ICU Medical, Inc | 95 |
| AincA® | Anesthesia Associates, Inc. | 76 |
| Medline/MMS Sales | Medline Industries, Inc. | 73 |
| Pediatric Ultra Flex®anesthesia Breathing Circuit | King Systems Corporation. | 71 |
| Vital Signs™ | Vyaire Medical, Inc. | 70 |
Showing 12 of 522. All products under Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K830475 | 1983-06-08 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-11-13 | Class II | Labeling Change Control | Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error. | 220 | 2014-07-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.