← Back to catalogue
Reduced Size Premium Headgear, International
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1059257
Identity
- Trade Name
- Reduced Size Premium Headgear, International EUDAMEDPremium Headgear FDA UDI
- Generic Name
- Anaesthesia mask strap, reusable FDA UDI
- Device Name
- Mask Accessory EUDAMEDReduced Size Premium Headgear, International FDA UDI
- Model / Reference
- 1059257 EUDAMEDReduced Size Premium Headgear, International FDA UDI
- Description
- Reduced Size Premium Headgear, International FDA UDI
Identifiers
- Catalog Number
- 1059257 FDA UDI
- Primary DI / UDI-DI
- 00606959060364 EUDAMEDFDA UDI
- Basic UDI-DI
- 0606959BM202LJ 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
Reduced Size Premium Headgear, International 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 51f5b5d5-396f-4295-8629-f124fa444b21 61 fields · synced Jun 18, 2026
- FDA UDI bc10da78-664e-48f0-b7f7-425a355ab076 36 fields · synced May 29, 2026