AirLife
Pediatric Manual Resuscitator; 40"(1.0m) Oxygen Resevoir Tubing, Pediatric Mask, Pressure Limiting Valve with lock, Pressure Manometer, PEEP Valve, 10' O2 Tubing
3manufacturers in China registered for this device type
79catalogue 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 | Carefusion, United States |
|---|---|
| FDA product code | OEV |
| Device type | Cardiopulmonary Resuscitation Aid Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2015-10-24 |
| Record revised | 2024-05-29 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -40 to 140 °F |
| Packaging | Case of 6, case of 12, case of 20, case of 10 |
| Sizes | Total volume 280 to 2100 ml; weight 0.33 to 0.5 kg; weight 205 to 562 g; total volume 0.25 to 3 l |
| Distribution end date | 2022-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2K8010C2 | Weight.33 kg | Withdrawn |
| 2K7105 | Weight 275.00 g | Withdrawn |
| 2K8004C2 | Weight.5 kg | Withdrawn |
| 2K8005C2 | Weight 0.50 kg | Withdrawn |
| 2K8000 | Weight.50 kg | Withdrawn |
| 2K8018 | Weight.40 kg | Withdrawn |
| 2K7103 | Weight 240.00 g | Withdrawn |
| 2K8021 | Weight.33 kg | Withdrawn |
| 2K7014 | Weight 562 g | Withdrawn |
| 2K7204 | Weight 240.00 g | Withdrawn |
| 2K7203 | Weight 240.00 g | Withdrawn |
| 2K80233 | Total Volume.25 l | Withdrawn |
| 2K8004 | Weight.5 kg | Withdrawn |
| 2K8035 | Weight.50 kg | Withdrawn |
| RE1100128B | Weight.50 kg | Withdrawn |
| RE2OC4936A | Weight.50 kg | Withdrawn |
| 2K8037C2 | Weight.40 kg | Withdrawn |
| 2K80303 | Total Volume 3.00 l | Withdrawn |
| 2K80253 | Total Volume.50 l | Withdrawn |
| 2K8037 | Weight.40 kg | Withdrawn |
| 2K7102 | Weight 240.00 g | Withdrawn |
| 2K8035M | Weight.50 kg | Withdrawn |
| 2K80252 | Total Volume.5 l | Withdrawn |
| 2K8010M | Weight.33 kg | Withdrawn |
| 2K8032M | Weight.50 kg | Withdrawn |
| 2K80292 | Total Volume 2.0 l | Withdrawn |
| 2K7200 | Weight 205.00 g | Withdrawn |
| 2K80302 | Total Volume 3.00 l | Withdrawn |
| 2K8008 | Weight 0.40 kg | Withdrawn |
| 2K8039M | Total Volume 1000.00 ml | Withdrawn |
| 2K8036 | Weight.50 kg | Withdrawn |
| 2K80232 | Total Volume.25 l | Withdrawn |
| 2K8005M | Weight 0.50 kg | Withdrawn |
| 2K8008M | Weight 0.40 kg | Withdrawn |
| 2K7106 | Weight 275.00 g | Withdrawn |
| 2K8005C2M | Weight 0.50 kg | Withdrawn |
| RESOC3867F | Weight.50 kg | Withdrawn |
| 2K8004M | Weight 0.50 kg | Withdrawn |
| 2K7207 | Weight 240.00 g | Withdrawn |
| 2K8805 | Weight 0.50 kg | Withdrawn |
| 2K8033 | Weight.50 kg | Withdrawn |
| 2K7006 | Total Volume 1500 ml | Withdrawn |
| 2K8004F | Weight 0.50 kg | Withdrawn |
| 2K7101 | Weight 240.00 g | Withdrawn |
| 2K8034 | Weight.50 kg | Withdrawn |
| 2K8005F | Weight 0.50 kg | Withdrawn |
| 2K7015 | Withdrawn | |
| 2K80251 | Total Volume.5 l | Withdrawn |
| 2K8001 | Weight.50 kg | Withdrawn |
| 2K80293 | Total Volume 2.0 l | Withdrawn |
| 2K8008F | Weight 0.40 kg | Withdrawn |
| 2K8032 | Weight.50 kg | Withdrawn |
| 2K8010C2M | Weight.33 kg | Withdrawn |
| 2K7201 | Weight 205.00 g | Withdrawn |
| 2K8035C2 | Weight.50 kg | Withdrawn |
| 2K8039 | Weight.40 kg | Withdrawn |
| RES307497A | Weight.50 kg | Withdrawn |
| 2K8008C2M | Weight 0.40 kg | Withdrawn |
| 2K8019 | Weight.33 kg | Withdrawn |
| 2K7009 | Weight 407.00 g | Withdrawn |
| 2K8010 | Weight.33 kg | Withdrawn |
| 2K8038M | Weight.33 kg | Withdrawn |
| 2K7005 | Weight 407.00 g | Withdrawn |
| 2K8038 | Weight.33 kg | Withdrawn |
| 2K8017 | Weight 0.50 kg | Withdrawn |
| 2K7002 | Weight 407.00 g | Withdrawn |
| 2K7206 | Weight 240.00 g | Withdrawn |
| 2K80273 | Total Volume 1.00 l | Withdrawn |
| 2K8039C2 | Weight.40 kg | Withdrawn |
| 2K7205 | Weight 240.00 g | Withdrawn |
| 2K8040 | Weight.33 kg | Withdrawn |
| 2K8010BR | Withdrawn | |
| 2K7208 | Weight 240.00 g | Withdrawn |
| 2K7007 | Weight 407.00 g | Withdrawn |
| 2K8008C2 | Weight.40 kg | Withdrawn |
| 2K8004C2M | Weight 0.50 kg | Withdrawn |
| 2K80272 | Total Volume 1.00 l | Withdrawn |
| 2K8020 | Weight.40 kg | Withdrawn |
| 2K8008BR | Withdrawn |
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 |
| Regard™ | ROi CPS LLC | 41 |
| AirLife™ | Airlife, Inc. | 38 |
| 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
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.