Bag, Reservoir
FDA product code BTC · Class I (low risk) · 21 CFR 868.5320 · Anesthesiology
19510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Warne Surgical Products, Ltd. 2
- Surgidyne, Inc. 1
- Pedia, LLC 1
- Zefon Medical Products 1
- Merit Medical Systems, Inc. 1
- Med-Plastics Intl., Inc. 1
- Precision Med Products, Ltd. 1
- Life Shield Healthcare Products, Inc. 1
- Med-Tek Corp. 1
- King Systems Corp. 1
- Cameron Medical Corp. 1
- Khi, Inc. 1
- Artec Environmental Monitoring Division 1
- Quest Medical, Inc. 1
- Life Design Systems, Inc. 1
- Esp Plastics, Inc. 1
- Dryden Corp. 1
- Mem Medical, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181424 | PeDIABTC · Traditional | Pedia, LLC | 09/25/2018SE |
| K940220 | Rebreather BagsBTC · Traditional | Zefon Medical Products | 05/27/1994SE |
| K932584 | Breathing BagsBTC · Traditional | Merit Medical Systems, Inc. | 07/16/1993SE |
| K932581 | Breathing BagsBTC · Traditional | Med-Plastics Intl., Inc. | 07/16/1993SE |
| K932496 | Precision Med Products, Ltd. Breathing BagsBTC · Traditional | Precision Med Products, Ltd. | 07/16/1993SE |
| K932191 | Breathing BagsBTC · Traditional | Life Shield Healthcare Products, Inc. | 07/02/1993SE |
| K894906 | Anesthesia Breathing Bags Sizes 1/2, 1,2,3 LiterBTC · Traditional | Med-Tek Corp. | 09/18/1989SE |
| K880680 | King Systems, Breathing BagBTC · Traditional | King Systems Corp. | 03/03/1988SE |
| K864822 | Varidyne 550, Models 12E,12M,24E & 24M Suction SysBTC · Traditional | Surgidyne, Inc. | 01/15/1987SE |
| K841412 | Rolled Neck W/TapBTC · Traditional | Warne Surgical Products, Ltd. | 04/18/1984SE |
| K841411 | Rolled Neck W/PlugBTC · Traditional | Warne Surgical Products, Ltd. | 04/18/1984SE |
| K830399 | Coupling/ValveBTC · Traditional | Khi, Inc. | 03/10/1983SE |
| K830056 | Artec Twist ValveBTC · Traditional | Artec Environmental Monitoring Division | 03/09/1983SE |
| K822216 | Volumetric ControllerBTC · Traditional | Quest Medical, Inc. | 08/16/1982SE |
| K822116 | Anesthesia Breathing Bag, Various SizesBTC · Traditional | Life Design Systems, Inc. | 08/16/1982SE |
| K821309 | Espree', Breathing BagBTC · Traditional | Esp Plastics, Inc. | 05/21/1982SE |
| K800155 | Disposal Liter Breathing BagBTC · Traditional | Dryden Corp. | 02/21/1980SE |
| K791910 | Three Liter Bag #M-512BTC · Traditional | Mem Medical, Inc. | 10/09/1979SE |
| K791463 | Para-VentBTC · Traditional | Cameron Medical Corp. | 09/17/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1450-2023 Class I | VentStar Bag Set (N) 110, MP00383Glued connections of the breathing circuit can become loose before or during ventilation resulting in… | Draeger Medical, Inc. | 04/17/2023Terminated |
| Z-1445-2023 Class I | VentStar breathing bag Set (P) 110, MP00384Glued connections of the breathing circuit can become loose before or during ventilation resulting in… | Draeger Medical, Inc. | 04/17/2023Terminated |
| Z-1367-2018 Class II | Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005…These products contain latex, but the following statement is not included on any level of product packaging:… | Teleflex Medical Europe Ltd | 03/15/2018Terminated |
| Z-1164-2008 | 2 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720058B, Medline…Separation from Bushing: The breathing bag may separate from the bushing during use. | Medline Industries Inc | 12/07/2007Terminated |
| Z-1163-2008 | 3 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720057B, Medline…Separation from Bushing: The breathing bag may separate from the bushing during use. | Medline Industries Inc | 12/07/2007Terminated |
| Z-1162-2008 | 1 Liter Latex-Free Breathing Bags; Reservoir Bag; Vendor Part Number: 720059B, Medline…Separation from Bushing: The breathing bag may separate from the bushing during use. | Medline Industries Inc | 12/07/2007Terminated |
| Z-2324-2008 | Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1…During setup and potentially during procedures, the breathing bag can become separated from the taped… | Ventlab Corporation | 12/05/2007Terminated |