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Pediatric Oxygen Mask High Concentration Non-rebreather, 7’ (2.1m) supply tube,…
EUDAMEDClass IIa (EU MDR)
Ref 1140-7-50Model Salter Oxygen MasksRef 1130-7-50Ref 1130TG-7-50Ref 1127-7-50
by Salter Labs
Identity
- Trade Name
- Pediatric Oxygen Mask High Concentration Non-rebreather, 7’ (2.1m) supply tube, elastic strap fixation. EUDAMEDOxygen Mask (Pediatric) High concentration non-rebreather, with safety vent. with 7’ (2.1 m) supply tube, Elastic Strap fixation. EUDAMEDPediatric Oxygen Mask High Concentration Non-rebreather. With Thread grip connector. 7 ft. tubing. Elastic strap style. Under the chin fit. Vinyl. EUDAMEDOxygen Mask (Pediatric) High Concentration partial rebreather, with 7’ (2.1 m) supply tube, Elastic Strap Fixation. EUDAMEDPediatric Oxygen Mask High Concentration Non-rebreather, 7’ (2.1m) supply tube, elastic strap fixation EUDAMEDOxygen Mask (Pediatric) High concentration non-rebreather, with safety vent. with 7’ (2.1 m) supply tube, Elastic Strap fixation EUDAMEDPediatric Oxygen Mask High Concentration Non-rebreather. With Thread grip connector. 7 ft. tubing. Elastic strap style. Under the chin fit. Vinyl EUDAMED
- Model / Reference
- Salter Oxygen Masks EUDAMED1140-7-50 EUDAMED1130-7-50 EUDAMED1130TG-7-50 EUDAMED1127-7-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411800112 EUDAMED10607411301404 EUDAMED10607411800785 EUDAMED10607411800761 EUDAMED
- Basic UDI-DI
- 0607411TF20014a_O2MaskLW EUDAMED
- Unit of Use DI
- 00607411800788 EUDAMED00607411800764 EUDAMED00607411301407 EUDAMED00607411800757 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
Pediatric Oxygen Mask High Concentration Non-rebreather, 7’ (2.1m) supply tube,… 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 (7)
- EUDAMED d4fa1123-c4f8-4746-a7bf-948612d4a67e 61 fields · synced Jul 16, 2026
- EUDAMED a702055d-5aba-479a-909a-d99946c99f66 61 fields · synced May 17, 2026
- EUDAMED 4a7f3640-32e4-4470-8938-5a533d18200d 61 fields · synced May 17, 2026
- EUDAMED 369e34d0-0d60-4dd2-b496-93910c05cad0 61 fields · synced May 18, 2026
- EUDAMED 18c26930-5708-41f8-9bc2-25cbb3cc33d2 61 fields · synced Jul 9, 2026
- EUDAMED de4d7826-86b8-4c8c-9a88-6c9a216eadc3 61 fields · synced Jul 10, 2026
- EUDAMED 2717df37-92cf-401f-bcf8-052ac9e1d26b 61 fields · synced Jul 16, 2026