Identity
- Trade Name
- Flexicare FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- Resuscitation Circuits EUDAMEDInfant Round Resuscitation Mask Size 2 FDA UDI
- Model / Reference
- 038-53-520U EUDAMEDFDA UDI
- Description
- Infant Round Resuscitation Mask Size 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055931117421 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055931117421 EUDAMED
- FDA Product Code
- BYG FDA UDI
- EMDN Code
- R03010199 VENTILATION MASKS - OTHER EUDAMED
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
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
Flexicare by Flexicare Medical Limited — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Flexicare Medical Limited
Sources (2)
- FDA UDI eb324ef2-0247-433b-ac43-0d0970dd5dce 33 fields · synced Oct 8, 2026
- EUDAMED 68984c2b-7609-42ff-b626-69af73e0a26e 61 fields · synced Oct 8, 2026