Identity
- Trade Name
- Compower FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is intended for prescription use. FDA UDI
- Model / Reference
- CP641000 FDA UDI
- Description
- CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is intended for prescription use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946430415219 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
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 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 b935ae3d-f9c1-498a-a2d6-71490a61318c 34 fields · synced Jun 1, 2026