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Oxygen Mask (Infant) Medium Concentration, 7’ (2.1 m) supply tube, elastic stra…
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 1114-7-50Model Salter Oxygen Masks
by Salter Labs
Identity
- Trade Name
- Oxygen Mask (Infant) Medium Concentration, 7’ (2.1 m) supply tube, elastic strap fixation EUDAMED
- Model / Reference
- Salter Oxygen Masks EUDAMED1114-7-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20607411801031 EUDAMED
- Basic UDI-DI
- 0607411TF20014a_O2MaskLW EUDAMED
- Unit of Use DI
- 00607411801037 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Oxygen Mask (Infant) Medium Concentration, 7’ (2.1 m) supply tube, elastic stra… by Salter Labs — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K912633 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0607411TF20014a_O2MaskLW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Salter Labs
- EUDAMED SRN
- US-MF-000007934
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 68fd13e1-ab46-4e57-8959-c66074178088 61 fields · synced Jun 18, 2026
- FDA 510(k) K912633 1 fields · synced May 18, 2026