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Mask Silicone Adult lg 5 reus
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref MP01915Model 208010PK19L030
Identity
- Trade Name
- Maske Silikon Erw gr 5 wiederverwendbar EUDAMEDMask Silicone Adult lg 5 reus FDA UDI
- Generic Name
- Anaesthesia face mask, reusable FDA UDI
- Model / Reference
- MP01915 EUDAMEDFDA UDI208010PK19L030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675252269 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751208010PK19L0302U EUDAMED
- Direct Marketing DI
- 04048675252269 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
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
Yes
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: Anaesthesia face mask, reusable
Mask Silicone Adult lg 5 reus by Drägerwerk AG & Co. KGaA — 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
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 77efff92-c2fc-480c-a88f-52713a663f27 33 fields · synced Jun 20, 2026
- EUDAMED e4d0f865-e9fc-4849-b27d-2d781a2f3b05 61 fields · synced Jun 20, 2026