Identity
- Trade Name
- Bi-Mask 6; 22 mm I.D. EUDAMEDBi-Mask FDA UDI
- Generic Name
- Anaesthesia face mask, reusable FDA UDI
- Device Name
- Face Masks - Bi-Mask EUDAMED#6 FDA UDI
- Model / Reference
- 35-65-226 EUDAMEDFDA UDI
- Description
- #6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14250105629627 EUDAMEDFDA UDI
- Basic UDI-DI
- 42501056-1.5.3-VR EUDAMED
- Direct Marketing DI
- 04250105629620 EUDAMED
- FDA Product Code
- BSJ FDA UDI
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
- GMDN Term
- Anaesthesia face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5550 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 22 Millimeter FDA UDI
Category: Anaesthesia face mask, reusable
Bi-Mask by VBM Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, reusable.
- Nasal Hood For Anesthesia Reusable Large — FLEXICARE MEDICAL LIMITED · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- Anesthesia Face Mask Silicone Reusable Adult Size 4 — FLEXICARE MEDICAL LIMITED · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- Anesthesia Face Mask Pre-Filled Inflatable Single Use Large Adult Size 5 — FLEXICARE MEDICAL LIMITED · Class I
- REPL SMALL NASAL HOOD — Parker Hannifin Corp. · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- REPL MEDIUM NASAL HOOD — Parker Hannifin Corp. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- VBM Medizintechnik GmbH
Sources (2)
- FDA UDI 715e511e-42c2-457c-a645-8c5f3dd4a456 36 fields · synced Jun 14, 2026
- EUDAMED ecbea113-3d49-4ca0-82fa-dc7b9590ffe6 61 fields · synced Jun 11, 2026