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Oxygen Mask (Adult) High Concentration non-rebreather, with safety vent. 7’ (2.…
EUDAMEDClass IIa (EU MDR)
Ref 8130TG-7-50Model Salter Oxygen Masks
by Salter Labs
Identity
- Trade Name
- Oxygen Mask (Adult) High Concentration non-rebreather, with safety vent. 7’ (2.1 m) supply tube with Thread Grip, Elastic strap fixation EUDAMED
- Model / Reference
- Salter Oxygen Masks EUDAMED8130TG-7-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411800433 EUDAMED
- Basic UDI-DI
- 0607411TF20014a_O2MaskLW EUDAMED
- Unit of Use DI
- 00607411800436 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 (Adult) High Concentration non-rebreather, with safety vent. 7’ (2.… by Salter Labs — Class IIa — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED 200e5762-6aa2-4b7f-a782-21fc1a0ec3be 61 fields · synced Jun 19, 2026