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Flow-Safe II
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10-57406Model Flow-Safe II CPAP System
Identity
- Trade Name
- Flow-Safe II EUDAMEDFlow-Safe II+ BiLevel Disposable CPAP System FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, single-use FDA UDI
- Device Name
- Flow-Safe II EUDAMED
- Model / Reference
- Flow-Safe II CPAP System EUDAMED10-57406 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 10641043574065 EUDAMEDFDA UDI
- Basic UDI-DI
- 0641043FLMU EUDAMED
- 510(k) Number
- K090710 FDA UDI
- FDA Product Code
- BYE FDA UDI
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
- GMDN Term
- CPAP/BPAP nasal mask, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5965 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Pulmonary resuscitator, manual, single-use
Flow-Safe II by Mercury Medical — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0641043FLMU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Mercury Medical
- EUDAMED SRN
- US-MF-000002015
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 00d9591a-8b8d-4ebc-afa9-5f858e508d74 61 fields · synced Jul 28, 2026
- FDA UDI f8401d57-8c9d-4fc2-81a4-fd24edc9684d 34 fields · synced May 30, 2026