Identity
- Trade Name
- compower FDA UDI
- Generic Name
- Cardiopulmonary resuscitation kit, single-use FDA UDI
- Device Name
- Cardiopulmonary resuscitation kit contains CPR Mask without Oxygen Port and one pair PVC glove. CPR Mask without Oxgen Port is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier that will direct expired air from the patient away from the user. It is intended for over the counter use. FDA UDI
- Model / Reference
- CP641002+PG FDA UDI
- Description
- Cardiopulmonary resuscitation kit contains CPR Mask without Oxygen Port and one pair PVC glove. CPR Mask without Oxgen Port is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier that will direct expired air from the patient away from the user. It is intended for over the counter use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946430400338 FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation kit, single-use FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary resuscitation kit, single-use
compower by Xiamen Compower Medical Tech. Co., Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary resuscitation kit, single-use.
- Ambu® SPUR® II Adult Resuscitator — Ambu A/S · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
- Ambu® SPUR® II Adult Resuscitator — Ambu A/S · Class II
- BROSELOW™ — Airlife, Inc. · Class II
- Ambu® SPUR® II Adult Resuscitator — Ambu A/S · Class II
- BROSELOW™ — Airlife, Inc. · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
- Ambu® SPUR® II Adult Resuscitator — Ambu A/S · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd
Sources (1)
- FDA UDI ebf1afec-3611-41c0-9793-b5cbca9c2449 33 fields · synced May 31, 2026