Identity
- Trade Name
- Battery module FDA UDI
- Generic Name
- Neonatal/adult intensive-care ventilator FDA UDI
- Model / Reference
- 6889000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07325710012642 FDA UDI
- FDA Product Code
- MNT FDA UDICBK FDA UDI
- GMDN Term
- Neonatal/adult intensive-care ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Neonatal/adult intensive-care ventilator
Battery module by Maquet Critical Care AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192604 also covers:
- Air inlet filter — Maquet Critical Care AB
- Battery module — Maquet Critical Care AB
- CABLE HOLDER — Maquet Critical Care AB
- Cabinet — Maquet Critical Care AB
- Dust filter 20 pcs/pkg — Maquet Critical Care AB
- EXPIRATORY CASSETTE, DARK GRAY — Maquet Critical Care AB
- GAS CYLINDER RESTRAINER KIT US — Maquet Critical Care AB
- Humidifier holder for rail 10 x 25/10 x 30 mm — Maquet Critical Care AB
- Mobile Cart, Flat Pack Servo-air — Maquet Critical Care AB
- Shelf base, Servo-air — Maquet Critical Care AB
- Support arm 179 — Maquet Critical Care AB
- TELEFLEX ADAPTER, HUMIDIFIER HOLDER — Maquet Critical Care AB
K230173 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maquet Critical Care AB
Sources (1)
- FDA UDI 62fb0e35-aa7c-4e65-a4cb-caf7bf450b92 33 fields · synced May 30, 2026