Identity
- Trade Name
- Premium Chin Strap EUDAMEDFDA UDI
- Generic Name
- Anaesthesia mask strap, reusable FDA UDI
- Device Name
- Mask Accessory EUDAMEDPremium Chin Strap FDA UDI
- Model / Reference
- 1012911 EUDAMEDPremium Chin Strap FDA UDI
- Description
- Premium Chin Strap FDA UDI
Identifiers
- Catalog Number
- 1012911 FDA UDI
- Primary DI / UDI-DI
- 00606959002142 EUDAMEDFDA UDI
- Basic UDI-DI
- 0606959BM202LJ EUDAMED
- Direct Marketing DI
- 00606959002142 EUDAMED
- FDA Product Code
- BTK FDA UDI
- EMDN Code
- R030180 RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Anaesthesia mask strap, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5560 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Premium Chin Strap by Respironics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0606959BM202LJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED a62cac45-e9bf-4bdc-ba1b-b9af22ac6d51 61 fields · synced Jun 18, 2026
- FDA UDI e3c9c0a8-552e-46f3-8dae-4d6351bf80f2 36 fields · synced May 29, 2026