Aisys

FDA UDI

Class II (US FDA UDI)

by Datex-Ohmeda Inc.

Identity

Trade Name: Aisys FDA UDI
Generic Name: Anaesthesia workstation, general-purpose FDA UDI
Device Name: AISYS CS2 WITH ET CONTROL FDA UDI
Model / Reference: CS2 WITH ET CONTROL FDA UDI
Description: AISYS CS2 WITH ET CONTROL FDA UDI

Identifiers

Primary DI / UDI-DI: 00195278588128 FDA UDI
510(k) Number: K170872 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

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

MRI Safety

MR Unsafe FDA UDI

Category: Anaesthesia workstation, general-purpose

Aisys by Datex-Ohmeda Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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A9800 Anesthesia Workstation — ORICARE INC. · Class II
A9800 Anesthesia Workstation — ORICARE INC. · Class II

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: Datex-Ohmeda Inc.

Sources (1)

FDA UDI d5185995-6646-418c-a548-fe04f1def1f3 35 fields · synced Jun 1, 2026