Identity
- Trade Name
- Flexicare FDA UDI
- Generic Name
- Airway pressure monitor, non-powered FDA UDI
- Device Name
- Single Use Manometer for use with Manual Resuscitator FDA UDI
- Model / Reference
- 038-71-966U FDA UDI
- Description
- Single Use Manometer for use with Manual Resuscitator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055931102328 FDA UDI
- FDA Product Code
- CAP FDA UDI
- GMDN Term
- Airway pressure monitor, non-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2600 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: Airway pressure monitor, non-powered
Flexicare by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Flexicare Medical Limited
Sources (1)
- FDA UDI ba9d6b63-71d2-4bad-98d2-be337d16dc7a 33 fields · synced May 30, 2026