Mask NovaStarTS, NIV, w/SE, S
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- NovaStar® TS NIV-Maske,SE,S EUDAMEDMask NovaStarTS,NIV,w/SE,S FDA UDI
- Generic Name
- Rebreathing oxygen face mask FDA UDI
- Model / Reference
- MP01579 EUDAMEDFDA UDI040552 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675040552 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04048675040552 EUDAMED
- 510(k) Number
- K081743 FDA UDI
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
- GMDN Term
- Rebreathing oxygen face mask FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Rebreathing oxygen face mask
Mask NovaStarTS, NIV, w/SE, S by Drägerwerk AG & Co. KGaA — Class II — 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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Cleared under the same submission
K081743 also covers:
- Mask ClassicStar Nasal NV, L — Drägerwerk AG & Co. KGaA
- Mask ClassicStar Nasal NV, M — Drägerwerk AG & Co. KGaA
- Mask ClassicStar Nasal NV, S — Drägerwerk AG & Co. KGaA
- Mask ClassicStar Nasal V, L — Drägerwerk AG & Co. KGaA
- Mask ClassicStar Nasal V, M — Drägerwerk AG & Co. KGaA
- Mask ClassicStar Nasal V, S — Drägerwerk AG & Co. KGaA
- Mask ClassicStar, NIV, SE, L — Drägerwerk AG & Co. KGaA
- Mask ClassicStar, NIV, SE, M — Drägerwerk AG & Co. KGaA
- Mask ClassicStar, NIV, SE, S — Drägerwerk AG & Co. KGaA
- Mask ClassicStar, NIV, w/AAV, L — Drägerwerk AG & Co. KGaA
- Mask ClassicStar, NIV, w/AAV, M — Drägerwerk AG & Co. KGaA
- Mask ClassicStar, NIV, w/AAV, S — Drägerwerk AG & Co. KGaA
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 1caacd54-7a4e-4e45-8b36-a9a87d3cc836 34 fields · synced Jun 19, 2026
- EUDAMED 99e94dbb-6020-4844-90f6-d83a9a4cc064 61 fields · synced Jun 19, 2026