Identity
- Trade Name
- Double adapter 22/22 FDA UDI
- Generic Name
- Neonatal/adult intensive-care ventilator FDA UDI
- Model / Reference
- M25647 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675009238 FDA UDI
- FDA Product Code
- BZA FDA UDIBYH FDA UDIBZO FDA UDI
- GMDN Term
- Neonatal/adult intensive-care ventilator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5810 FDA UDI868.5995 FDA UDI868.5975 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Neonatal/adult intensive-care ventilator
Double adapter 22/22 by Drägerwerk AG & Co. KGaA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (1)
- FDA UDI 62f3e828-da48-4a02-90fd-89b5358e90d3 33 fields · synced May 31, 2026