Identity
- Trade Name
- MFASCO FDA UDI
- Generic Name
- Cardiopulmonary resuscitation kit, single-use FDA UDI
- Device Name
- Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port and two pieces alcohol pads. 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+2A FDA UDI
- Description
- Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port and two pieces alcohol pads. 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
- 06946430421807 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
Yes
FDA UDI
Over-the-Counter
No
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
Mfasco by Xiamen Compower Medical Tech. Co., Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 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 |
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Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd
Sources (1)
- FDA UDI dad3ecd6-71c0-43c3-ad8f-62b0283ccdc9 33 fields · synced May 30, 2026