Identity
- Trade Name
- AFGO adapter kit onsite upgrade FDA UDI
- Generic Name
- Anaesthesia workstation, general-purpose FDA UDI
- Model / Reference
- 6887999 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07325710010464 FDA UDI
- 510(k) Number
- K191027 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- GMDN Term
- Anaesthesia workstation, general-purpose FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5160 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Anaesthesia workstation, general-purpose
AFGO adapter kit onsite upgrade by Maquet Critical Care AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia workstation, general-purpose.
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- A9800 Anesthesia Workstation — ORICARE INC. · Class II
- A9800 Anesthesia Workstation — ORICARE INC. · Class II
- A9800 Anesthesia Workstation — ORICARE INC. · Class II
- A9800 Anesthesia Workstation — ORICARE INC. · Class II
- A9800 Anesthesia Workstation — ORICARE INC. · Class II
Cleared under the same submission
K191027 also covers:
- AFGO kit (onsite upgrade) — Maquet Critical Care AB
- Extra Volume reflector — Maquet Critical Care AB
- Flexible manual breathing bag arm — Maquet Critical Care AB
- Gas sampling line (M/M connectors) 4.5m — Maquet Critical Care AB
- Horizontal short rail DIN — Maquet Critical Care AB
- Suction tip holder — Maquet Critical Care AB
- Tubing hook large — Maquet Critical Care AB
- Tubing hook small — Maquet Critical Care AB
- Vaporizer Desflurane, Saf-Fil — Maquet Critical Care AB
- Vaporizer Isoflurane, MAQUET filling — Maquet Critical Care AB
- Vaporizer Sevoflurane, MAQUET filling — Maquet Critical Care AB
- Vaporizer Sevoflurane, QUICK FILL — 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 d96e728d-614a-4107-86b2-ae14498fac16 33 fields · synced May 30, 2026