Identity
- Trade Name
- Spiracle Technology - FERNO2 - DAN FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- CPR Mask FDA UDI
- Model / Reference
- T50520 FDA UDI
- Description
- CPR Mask FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814940021564 FDA UDI
- 510(k) Number
- K171961 FDA UDI
- FDA Product Code
- KGB FDA UDICBP FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5570 FDA UDI868.5870 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary resuscitation mask, single-use
Spiracle Technology - FERNO2 - DAN by Spiracle Technology — Class I — 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.
- 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
- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Spiracle Technology
Sources (1)
- FDA UDI 2ebc3197-8f0c-478d-9a46-4cae3b4194e9 34 fields · synced Jun 8, 2026