Identity
- Trade Name
- Flexicare FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- Infant Resuscitator, Pressure Relief 40cmH20, Mask Size 0 and 1, w/Corrugated Tubing FDA UDI
- Model / Reference
- 038-73-980U FDA UDI
- Description
- Infant Resuscitator, Pressure Relief 40cmH20, Mask Size 0 and 1, w/Corrugated Tubing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055931104001 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 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: Pulmonary resuscitator, manual, single-use
Flexicare by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Ventlab — Ventlab Corp. · Class II
- Ambu® SPUR® II Pediatric 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Flexicare Medical Limited
Sources (1)
- FDA UDI 62bb9da1-44eb-4a4c-bb53-72a5b8a77211 33 fields · synced Jun 1, 2026