AirLife™
Pediatric Manual Resuscitator 40” (1.0 m) Oxygen Reservoir Tubing, Masks (Toddler, Child, Adult), Pressure Limiting Valve with Lock
3manufacturers in China registered for this device type
38catalogue numbers in this listing
Who Else Makes It
All of them in Fujian. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Xiamen Compower Medical Tech. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
Record
| Listed by | Airlife, Inc., United States |
|---|---|
| FDA product code | OEV |
| Device type | Cardiopulmonary Resuscitation Aid Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Premarket notification | Exempt |
| Record published | 2021-05-03 |
| Record revised | 2025-04-17 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -40 to 50 °C |
| Packaging | Case of 6, case of 20, case of 12, case of 10 |
| Sizes | Weight 0.5 kg; total volume 2100 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2K7201 | In distribution | |
| 2K80252 | In distribution | |
| 2K8005C2 | In distribution | |
| 2K7204 | In distribution | |
| 2K8035C2 | In distribution | |
| 2K7009 | In distribution | |
| 2K8010BR | In distribution | |
| 2K80233 | In distribution | |
| 2K8037C2 | In distribution | |
| 2K8004C2 | In distribution | |
| 2K80232 | In distribution | |
| 2K7002 | In distribution | |
| 2K8005F | Weight 0.5 kg | In distribution |
| 2K8008BR | In distribution | |
| 2K80292 | In distribution | |
| 2K7000 | In distribution | |
| 2K8017 | Weight 0.5 kg | In distribution |
| 2K8035M | Total Volume 2100 ml | In distribution |
| 2K8005M | Total Volume 2100 ml | In distribution |
| 2K8005C2M | In distribution | |
| 2K7103 | In distribution | |
| 2K7006 | In distribution | |
| 2K7102 | In distribution | |
| 2K8004C2M | In distribution | |
| 2K8004M | Total Volume 2100 ml | In distribution |
| 2K80272 | In distribution | |
| 2K8004 | In distribution | |
| 2K8036 | Weight 0.5 kg | In distribution |
| 2K80293 | In distribution | |
| RES90RESUD | In distribution | |
| 2K7207 | In distribution | |
| 2K8005 | Total Volume 2100 ml | In distribution |
| 2K80302 | In distribution | |
| 2K7200 | In distribution | |
| 2K80253 | In distribution | |
| 2K7005 | In distribution | |
| 2K8004F | Weight 0.5 kg | In distribution |
| 2K7203 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambu® Spur® II Adult Resuscitator | Ambu A/S | 97 |
| Ambu® Spur® II Pediatric Resuscitator | Ambu A/S | 88 |
| AirLife | Carefusion | 79 |
| Regard™ | ROi CPS LLC | 41 |
| Ambu® Spur® II Infant Resuscitator | Ambu A/S | 23 |
| SuperNO2VA | Airlife, Inc. | 6 |
| Mark IV Baby Resuscitator | Ambu A/S | 5 |
| Curaplex | Bound Tree Medical, LLC | 3 |
| Mark IV Resuscitatorwith single shutter patient valve | Ambu A/S | 2 |
| EMI | Xiamen Compower Medical Tech. Co., Ltd. | 1 |
| Spur® II Infant Resuscitator | Ambu A/S | 1 |
| Ambu® Spur® II Pedi. BAG Resvr. | Ambu A/S | 1 |
Showing 12 of 16. All products under Cardiopulmonary Resuscitation Aid Kit
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Vyaire Medical, Inc. | UDI-DI | 2024-01-10 | Class I | Process control | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilatio | 8,220 units |
| Vyaire Medical, Inc. | UDI-DI | 2024-01-10 | Class I | Process control | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilatio | 3,636 units |
| Vyaire Medical, Inc. | UDI-DI | 2024-01-10 | Class I | Process control | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilatio | 3,683,407 units |
| Vyaire Medical, Inc. | UDI-DI | 2024-01-10 | Class I | Process control | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilatio | 2,070 units |
| Vyaire Medical, Inc. | UDI-DI | 2024-01-10 | Class I | Process control | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilatio | 4,572 units |
| Vyaire Medical, Inc. | UDI-DI | 2024-01-10 | Class I | Process control | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilatio | 1,020,330 units |
| Vyaire Medical, Inc. | UDI-DI | 2024-01-10 | Class I | Process control | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilatio | 1,800,000 units |
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.