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Mask O2Star w 22mm OD M/L
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref MP01926Model 420576
Identity
- Trade Name
- Maske O2Star m 22mm OD M/L EUDAMEDMask O2Star w 22mm OD M/L FDA UDI
- Generic Name
- Rebreathing oxygen face mask FDA UDI
- Model / Reference
- MP01926 EUDAMEDFDA UDI420576 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675420576 EUDAMED04048675382485 FDA UDI
- Basic UDI-DI
- B-04048675420576 EUDAMED
- FDA Product Code
- BYG FDA UDI
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
- GMDN Term
- Rebreathing oxygen face mask FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rebreathing oxygen face mask
Mask O2Star w 22mm OD M/L by Drägerwerk AG & Co. KGaA — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Rebreathing oxygen face mask.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 23f9f00d-44f5-43d3-ade6-fc7fa40a588b 33 fields · synced Oct 8, 2026
- EUDAMED 8b79b7e9-2b5f-4d23-9718-4e1c3eecc83e 61 fields · synced Jun 18, 2026