Product code BTC
- Device name
- Bag, Reservoir
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5320
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181424 | PeDIA | Pedia, LLC | 2018-09-25 |
| K940220 | REBREATHER BAGS | Zefon Medical Products | 1994-05-27 |
| K932584 | BREATHING BAGS | Merit Medical Systems, Inc. | 1993-07-16 |
| K932581 | BREATHING BAGS | Med-Plastics Intl., Inc. | 1993-07-16 |
| K932496 | PRECISION MED PRODUCTS, LTD. BREATHING BAGS | Precision Med Products, Ltd. | 1993-07-16 |
| K932191 | BREATHING BAGS | Life Shield Healthcare Products, Inc. | 1993-07-02 |
| K894906 | ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER | Med-Tek Corp. | 1989-09-18 |
| K880680 | KING SYSTEMS, BREATHING BAG | King Systems Corp. | 1988-03-03 |
| K864822 | VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS | Surgidyne, Inc. | 1987-01-15 |
| K841411 | ROLLED NECK W/PLUG | Warne Surgical Products, Ltd. | 1984-04-18 |
| K841412 | ROLLED NECK W/TAP | Warne Surgical Products, Ltd. | 1984-04-18 |
| K830399 | COUPLING/VALVE | Khi, Inc. | 1983-03-10 |
| K830056 | ARTEC TWIST VALVE | Artec Environmental Monitoring Division | 1983-03-09 |
| K822216 | VOLUMETRIC CONTROLLER | Quest Medical, Inc. | 1982-08-16 |
| K822116 | ANESTHESIA BREATHING BAG, VARIOUS SIZES | Life Design Systems, Inc. | 1982-08-16 |
| K821309 | ESPREE', BREATHING BAG | Esp Plastics, Inc. | 1982-05-21 |
| K800155 | DISPOSAL LITER BREATHING BAG | Dryden Corp. | 1980-02-21 |
| K791910 | THREE LITER BAG #M-512 | Mem Medical, Inc. | 1979-10-09 |
| K791463 | PARA-VENT | Cameron Medical Corp. | 1979-09-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04816415501447 | BREATHING BAG single use 1000 | ASSOMEDIKA, OOO | 2026-05-27 |
| 04816415501454 | BREATHING BAG single use 2000 | ASSOMEDIKA, OOO | 2026-05-27 |
| 04816415501461 | BREATHING BAG single use 3000 | ASSOMEDIKA, OOO | 2026-05-27 |
| 04816415501478 | BREATHING BAG reusable 500 | ASSOMEDIKA, OOO | 2026-05-27 |
| 04816415501485 | BREATHING BAG reusable 1000 | ASSOMEDIKA, OOO | 2026-05-27 |
| 04816415501492 | BREATHING BAG reusable 2000 | ASSOMEDIKA, OOO | 2026-05-27 |
| 04816415501508 | BREATHING BAG reusable 3000 | ASSOMEDIKA, OOO | 2026-05-27 |
| 04816415501430 | BREATHING BAG single use 500 | ASSOMEDIKA, OOO | 2026-05-27 |
| 08697645018198 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2026-04-17 |
| 10080196984848 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 10080196984930 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 10080196984916 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 10080196984855 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 10080196984787 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 10080196984770 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 10080196984251 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 10080196984213 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 10080196984190 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 10190752136137 | Vital Signs™ | AirLife Finland Oy | 2022-06-16 |
| 10190752136144 | Vital Signs™ | AirLife Finland Oy | 2022-06-16 |
| 10190752136151 | Vital Signs™ | AirLife Finland Oy | 2022-06-16 |
| 10190752136168 | Vital Signs™ | AirLife Finland Oy | 2022-06-16 |
| 10190752136199 | Vital Signs™ | AirLife Finland Oy | 2022-06-16 |
| 10190752108950 | Vital Signs™ | AirLife Finland Oy | 2021-11-08 |
| 10190752137004 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2021-11-08 |
| 10190752139732 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2021-11-08 |
| 10190752108936 | Vital Signs™ | AirLife Finland Oy | 2021-07-06 |
| 10190752108943 | Vital Signs™ | AirLife Finland Oy | 2021-07-06 |
| 10190752140073 | Vital Signs™ | AirLife Finland Oy | 2021-07-06 |
| 08051736003768 | 3 L NON STERILE WASTE BAGS | BELLCO SRL | 2021-05-30 |