Identity
- Trade Name
- EXPIRATORY CASSETTE, SERVO-n FDA UDI
- Generic Name
- Neonatal intensive-care ventilator FDA UDI
- Model / Reference
- 6693750 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17325710004132 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Neonatal 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neonatal intensive-care ventilator
EXPIRATORY CASSETTE, SERVO-n by Maquet Critical Care AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Neonatal intensive-care ventilator.
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Cleared under the same submission
K151814 also covers:
- CABLE HOLDER — Maquet Critical Care AB
- CAPNOSTAT 5 — Maquet Critical Care AB
- CO2 ANALYZER MODULE — Maquet Critical Care AB
- CO2 ANALYZER MODULE CAPNOSTAT 5 — Maquet Critical Care AB
- EXPIRATORY CASSETTE, DARK GRAY — Maquet Critical Care AB
- GAS CYLINDER RESTRAINER KIT — Maquet Critical Care AB
- GAS CYLINDER RESTRAINER KIT US — Maquet Critical Care AB
- HUMIDIFIER HOLDER — Maquet Critical Care AB
- Humidification holder assy — Maquet Critical Care AB
- MOBILE CART — Maquet Critical Care AB
- PENDANT BED/HOLDER — Maquet Critical Care AB
- Rail clamp 10x25, Humidifier holder — Maquet Critical Care AB
K180098 also covers:
- CABLE HOLDER — Maquet Critical Care AB
- CAPNOSTAT 5 — Maquet Critical Care AB
- CO2 ANALYZER MODULE — Maquet Critical Care AB
- CO2 ANALYZER MODULE CAPNOSTAT 5 — Maquet Critical Care AB
- EXPIRATORY CASSETTE, DARK GRAY — Maquet Critical Care AB
- GAS CYLINDER RESTRAINER KIT US — Maquet Critical Care AB
- HUMIDIFIER HOLDER — Maquet Critical Care AB
- Humidification holder assy — Maquet Critical Care AB
- MOBILE CART — Maquet Critical Care AB
- PENDANT BED/HOLDER — Maquet Critical Care AB
- Rail clamp 10x25, Humidifier holder — Maquet Critical Care AB
- SHELF BASE — Maquet Critical Care AB
K201874 also covers:
- CABLE HOLDER — Maquet Critical Care AB
- CAPNOSTAT 5 — Maquet Critical Care AB
- Drawer for Low mobile carts — Maquet Critical Care AB
- EXPIRATORY CASSETTE, DARK GRAY — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maquet Critical Care AB
Sources (1)
- FDA UDI 88c8add2-d10a-4cf6-9558-d46fd3ebcdfe 33 fields · synced Jun 6, 2026