Non Invasive Ventilation face mask, size S
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Non Invasive Ventilation face mask, size S EUDAMEDNIV Mask (S) disposable MAQUET FDA UDI
- Generic Name
- Anaesthesia face mask, single-use FDA UDI
- Device Name
- Non Invasive Ventilation Face Mask EUDAMED
- Model / Reference
- 6691980 EUDAMED6694590 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07325710002377 EUDAMEDFDA UDI
- Basic UDI-DI
- 7325710002378G EUDAMED
- FDA Product Code
- BYG FDA UDI
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
- GMDN Term
- Anaesthesia face mask, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- Not 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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Anaesthesia face mask, single-use
Non Invasive Ventilation face mask, size S by Maquet Critical Care AB — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
- Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant — Dynarex Corp. · Class I
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7325710002378G | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Maquet Critical Care AB
- EUDAMED SRN
- SE-MF-000001264
Sources (2)
- EUDAMED f45aada6-cfc6-4c6d-bc99-d0efcc3b8e80 61 fields · synced Jul 13, 2026
- FDA UDI 1b27b4e3-cc78-4507-bfde-7e54fd9597b6 33 fields · synced May 29, 2026