Mask ClassicStar, NIV, w/AAV, L
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Maske ClassicStar,NIV,mAAV,GrL EUDAMEDMask ClassicStar,NIV,w/AAV,L FDA UDI
- Generic Name
- Rebreathing oxygen face mask FDA UDI
- Model / Reference
- MP01572 EUDAMEDFDA UDI2080026K19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675251613 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867512080026K19Z000P8 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
Yes
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 ClassicStar, NIV, w/AAV, L by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rebreathing oxygen face mask.
- DUAL MASK-ADULT MALE NOSE CLIP MC WITH CO2 MONIT 7FT (USA) — FLEXICARE MEDICAL LIMITED · Class II
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- Mask — Beijing Rongrui-Century Science & Technology Co. , Ltd. · Class IIa
- AMARA MASK WITH RS FRAME AND HEADGEAR LARGE, INTL — Respironics Inc. · Class IIa
- ClasStar, GanzGesMask, NIV, AAV, L — Drägerwerk AG & Co. KGaA · Class IIa
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Oro-Nasal Mask — HANS RUDOLPH, INC. · Class IIa
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, M — Drägerwerk AG & Co. KGaA
- Mask ClassicStar, NIV, w/AAV, S — Drägerwerk AG & Co. KGaA
- Mask NovaStarTS, NIV, w/AAV, L — Drägerwerk AG & Co. KGaA
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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 d5096a7f-b500-4f56-902d-cf79212c1f30 34 fields · synced Jul 9, 2026
- EUDAMED 7077cb2f-e170-48c9-ac05-3e8c214b2c09 61 fields · synced Jul 9, 2026