Flow-Safe II
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Flow-Safe II EUDAMEDFlow-Safe II EZ 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 EUDAMED10-57321 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 10641043573211 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Pulmonary resuscitator, manual, single-use
Flow-Safe II by Mercury Medical — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Pulmonary resuscitator, manual, single-use.
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- Ventlab — Ventlab Corp. · Class II
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090710 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0641043FLMU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mercury Medical
- EUDAMED SRN
- US-MF-000002015
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 75587822-6439-43c0-ad7d-3c8624b89be0 61 fields · synced Jul 26, 2026
- FDA UDI 67745eea-24ac-44ac-9725-ca2ab574273b 34 fields · synced May 24, 2026
- FDA 510(k) K090710 1 fields · synced May 18, 2026