Identity
- Trade Name
- Compower FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- It 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 theuser.It is intended for over the counter use. FDA UDI
- Model / Reference
- CP641002 FDA UDI
- Description
- It 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 theuser.It is intended for over the counter use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946430400185 FDA UDI
- 510(k) Number
- K171961 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5870 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
No
FDA UDI
Over-the-Counter
Yes
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 mask, single-use
Compower by Xiamen Compower Medical Tech. Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171961 also covers:
- Medline — MEDLINE INDUSTRIES, INC.
- Spiracle Technology - FERNO2 - DAN — SPIRACLE TECHNOLOGY
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
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 43abdc4c-07c2-4719-9ef6-9494d37c8714 35 fields · synced May 30, 2026