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 the user. It is intended for over the counter use for infants with body weight up to 10 kg (22 lbs). FDA UDI
- Model / Reference
- CP641007 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 the user. It is intended for over the counter use for infants with body weight up to 10 kg (22 lbs). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946430400246 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 571a303d-a7d2-4145-b126-fcf84e42ac4a 34 fields · synced May 30, 2026