Identity
- Trade Name
- Sampling Line 2,5m 25Pc FDA UDI
- Generic Name
- Anaesthesia workstation, general-purpose FDA UDI
- Model / Reference
- 6522770 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17325710003166 FDA UDI
- 510(k) Number
- K133958 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anaesthesia workstation, general-purpose
Sampling Line 2, 5m 25Pc 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.
- A9800 Anesthesia Workstation — ORICARE INC. · Class II
- A9800 Anesthesia Workstation — ORICARE INC. · Class II
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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
K133958 also covers:
- Absorber sealing, 2 each — Maquet Critical Care AB
- Adapter assy — Maquet Critical Care AB
- Adjustable arm for param. modules — Maquet Critical Care AB
- Cable Suport Arm — Maquet Critical Care AB
- Conn Tube 22mm Int 50m disposable — Maquet Critical Care AB
- Cover for vaporizer slot — Maquet Critical Care AB
- Gas sampling line 2.0m (M/M) — Maquet Critical Care AB
- Manual Breathing bag support arm, rigid — Maquet Critical Care AB
- Maquet filling adapter isoflur — Maquet Critical Care AB
- Maquet filling adapter sevoflur — Maquet Critical Care AB
- Patient cassette complete — Maquet Critical Care AB
- Vaporizer Desflurane, Saf-T-Fil — 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 4dd46dd3-40de-43d9-a67c-bc9ff712f776 33 fields · synced May 30, 2026