Identity
- Trade Name
- EMI FDA UDI
- Generic Name
- Cardiopulmonary resuscitation kit, single-use FDA UDI
- Device Name
- The cardiopulmonary resuscitation aid kit comprises of one CPR mask with Oxygen Port, two pieces alcohol pads and one pair PVC glove. This kit is designed for mouth to mask ventilation to health emergency patients requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing patient. It functions as a barrier to direct expired air from the patient away from the user. It can be used with supplemental oxygen when needed. FDA UDI
- Model / Reference
- CP641000+2A+PG FDA UDI
- Description
- The cardiopulmonary resuscitation aid kit comprises of one CPR mask with Oxygen Port, two pieces alcohol pads and one pair PVC glove. This kit is designed for mouth to mask ventilation to health emergency patients requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing patient. It functions as a barrier to direct expired air from the patient away from the user. It can be used with supplemental oxygen when needed. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946430414366 FDA UDI
- FDA Product Code
- OEV FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Emi by Xiamen Compower Medical Tech. Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary resuscitation kit, single-use.
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- 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd
Sources (1)
- FDA UDI 4b0f3c38-c86d-42c4-a8b3-27c64a43c2e6 33 fields · synced May 31, 2026