Identity
- Trade Name
- Drawer for Low mobile carts FDA UDI
- Generic Name
- General-purpose intensive-care ventilator FDA UDI
- Model / Reference
- 6890365 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07325710012673 FDA UDI
- 510(k) Number
- K201874 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- General-purpose 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose intensive-care ventilator
Drawer for Low mobile carts by Maquet Critical Care AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose intensive-care ventilator.
- Inspiration 7i Ventilator System — eVent Medical, Ltd. · Class II
- eVolution 3e Ventilator — eVent Medical, Ltd. · Class II
- EVOLUTION — eVent Medical, Ltd. · Class II
- Inspiration 7i Ventilator System — eVent Medical, Ltd. · Class II
- Inspiration 7i Ventilator System — eVent Medical, Ltd. · Class II
Cleared under the same submission
K201874 also covers:
- CABLE HOLDER — Maquet Critical Care AB
- CAPNOSTAT 5 — Maquet Critical Care AB
- EXPIRATORY CASSETTE, DARK GRAY — Maquet Critical Care AB
- EXPIRATORY CASSETTE, SERVO-n — Maquet Critical Care AB
- GAS CYLINDER RESTRAINER KIT US — Maquet Critical Care AB
- HUMIDIFIER HOLDER — Maquet Critical Care AB
- Heliox Servo adapter kit — Maquet Critical Care AB
- MOBILE CART — Maquet Critical Care AB
- PENDANT BED/HOLDER — Maquet Critical Care AB
- SHELF BASE — Maquet Critical Care AB
- THERMOSHELL, EXP CASSETTE — Maquet Critical Care AB
- USER INTERFACE HOLDER — Maquet Critical Care AB
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 |
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Manufacturer
- Manufacturer
- Maquet Critical Care AB
Sources (1)
- FDA UDI db23a3b0-7641-4793-8b13-233cd3219214 33 fields · synced May 30, 2026