Mask Silicone PremieXS 00 reus
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Maske Sil Frühge XS 00 wiederverwendbar EUDAMEDMask Silicone PremieXS 00 reus FDA UDI
- Generic Name
- Anaesthesia face mask, single-use FDA UDI
- Model / Reference
- MP02900 EUDAMEDFDA UDI208010PK19L030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675381303 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751208010PK19L0302U EUDAMED
- Direct Marketing DI
- 04048675381303 EUDAMED
- FDA Product Code
- BSJ FDA UDI
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
- GMDN Term
- Anaesthesia face mask, single-use 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
Single Use
No
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
No
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
No
Manufacturing Date
Yes
Category: Anaesthesia face mask, single-use
Mask Silicone PremieXS 00 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, single-use.
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- King Mask — Ambu A/S · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 b41af03b-4e2b-461f-a6e9-255a8d195287 33 fields · synced Jul 15, 2026
- EUDAMED d0aba815-0f99-4e8d-bd6f-686aa6194fec 61 fields · synced Jul 15, 2026