Identity
- Trade Name
- A9800 Anesthesia Workstation FDA UDI
- Generic Name
- Anaesthesia workstation, general-purpose FDA UDI
- Device Name
- Anesthesia Workstation with standard features plus: Side Stream Gas. English USA Language. USA Power Setup FDA UDI
- Model / Reference
- A9800 FDA UDI
- Description
- Anesthesia Workstation with standard features plus: Side Stream Gas. English USA Language. USA Power Setup FDA UDI
Identifiers
- Catalog Number
- 0081508502002 FDA UDI
- Primary DI / UDI-DI
- 00815085020023 FDA UDI
- 510(k) Number
- K131790 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Anaesthesia workstation, general-purpose
A9800 Anesthesia Workstation by Oricare Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131790 also covers:
- A9800 Anesthesia Workstation — ORICARE INC.
- A9800 Anesthesia Workstation — ORICARE INC.
- A9800 Anesthesia Workstation — ORICARE INC.
- A9800 Anesthesia Workstation — ORICARE INC.
- A9800 Anesthesia Workstation — ORICARE INC.
- A9800 Anesthesia Workstation — ORICARE INC.
- A9800 Anesthesia Workstation — ORICARE INC.
- A9800 Anesthesia Workstation — ORICARE INC.
- A9800 Anesthesia Workstation — ORICARE INC.
- A9800 Anesthesia Workstation — ORICARE INC.
- A9800 Anesthesia Workstation — ORICARE INC.
- A9800 Anesthesia Workstation — ORICARE INC.
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
- Oricare Inc.
Sources (1)
- FDA UDI 77ce7d7a-1389-40e2-a6e6-a57dbb5650c8 37 fields · synced May 30, 2026