Identity
- Trade Name
- Mask ClassicStar,NIV,SE,L FDA UDI
- Generic Name
- Rebreathing oxygen face mask FDA UDI
- Model / Reference
- MP01575 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675041139 FDA UDI
- 510(k) Number
- K081743 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Rebreathing oxygen face mask FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Rebreathing oxygen face mask
Mask ClassicStar, NIV, SE, L by Drägerwerk AG & Co. KGaA — Class II — FDA UDI — listed in FDA GUDID — 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
- Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class I
- Ventlab — Ventlab Corp. · Class I
- 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, 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
- Mask NovaStarTS, NIV, w/AAV, L — Drägerwerk AG & Co. KGaA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (1)
- FDA UDI 55d1d562-6117-4968-88fe-7e9d178f486c 34 fields · synced May 31, 2026