Getinge 91-Series

FDA UDI

Class II (US FDA UDI)

by Getinge Disinfection, Inc.

Identity

Trade Name: GETINGE 91-SERIES FDA UDI
Generic Name: Surgical utensil washer/disinfector FDA UDI
Device Name: WASHER DISINFECTOR 9122 AWRFS. Customized 9122-002 equipped with Automatic Water Rack Flush System (AWRFS). FDA UDI
Model / Reference: 9122 FDA UDI
Description: WASHER DISINFECTOR 9122 AWRFS. Customized 9122-002 equipped with Automatic Water Rack Flush System (AWRFS). FDA UDI

Identifiers

Catalog Number: 9122-002K960 FDA UDI
Primary DI / UDI-DI: 07340153710139 FDA UDI
FDA Product Code: MEC FDA UDI
GMDN Term: Surgical utensil washer/disinfector FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6992 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical utensil washer/disinfector

Getinge 91-Series by Getinge Disinfection, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Getinge Disinfection, Inc.

Sources (1)

FDA UDI 801310c7-e658-446e-84e3-e58585960cdb 34 fields · synced Jun 1, 2026