A9800 Anesthesia Workstation

FDA UDI

Class II (US FDA UDI)

by Oricare Inc.

Identity

Trade Name: A9800 Anesthesia Workstation FDA UDI
Generic Name: Anaesthesia workstation, general-purpose FDA UDI
Device Name: Anesthesia Workstation with standard features only: French Canadian. USA Power Setup FDA UDI
Model / Reference: A9800 FDA UDI
Description: Anesthesia Workstation with standard features only: French Canadian. USA Power Setup FDA UDI

Identifiers

Catalog Number: 0081508502016 FDA UDI
Primary DI / UDI-DI: 00815085020160 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

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

Similar devices

Also classified as Anaesthesia workstation, general-purpose.

Extra Volume reflector — Maquet Critical Care AB · Class II
Secretion jar set w. clamp — Drägerwerk AG & Co. KGaA · Class II
Vaporizer Desflurane, Saf-Fil — Maquet Critical Care AB · Class II
Vaporizer Sevoflurane, MAQUET filling — Maquet Critical Care AB · Class II
Dustfilter 40pcs Reus.Abso.Flow-i — Maquet Critical Care AB · Class I
AFGO kit (onsite upgrade) — Maquet Critical Care AB · Class II
Tubing hook large — Maquet Critical Care AB · Class II
Gas sampling line 2.0m (M/M) — Maquet Critical Care AB · Class II

Cleared under the same submission

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: Oricare Inc.

Sources (1)

FDA UDI e5646fce-7b20-4258-93b0-0ec6402efbb0 37 fields · synced May 30, 2026