Identity
- Trade Name
- Paediatric Mask; Infant #1; 15 mm O.D. EUDAMEDPaediatric Mask; Infant FDA UDI
- Generic Name
- Anaesthesia face mask, reusable FDA UDI
- Device Name
- Face Masks - Paediatric Mask EUDAMED#1; 15 mm OD. FDA UDI
- Model / Reference
- 88-11-001 EUDAMEDFDA UDI
- Description
- #1; 15 mm OD. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14250105630531 EUDAMEDFDA UDI
- Basic UDI-DI
- 42501056-1.5.7-W5 EUDAMED
- FDA Product Code
- BYW FDA UDI
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
- GMDN Term
- Anaesthesia face mask, reusable FDA UDI
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5675 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
Category: Anaesthesia face mask, reusable
Paediatric Mask +1 more model by VBM Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 2 models — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, reusable.
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- AincA® — Anesthesia Associates, Inc. · Class I
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- AincA® — Anesthesia Associates, Inc. · Class I
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- 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 7feca470-a775-40fc-89e0-c2d363257411 36 fields · synced Jul 22, 2026
- EUDAMED 80aec943-58f9-46a2-97a0-4e52aa32ac24 61 fields · synced Jul 22, 2026