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AN4000.61 EOGas 4 Ethylene Oxide Gas Sterilizer, 230V

FDA UDI

Class II (US FDA UDI)

by Andersen Sterilizers, Inc.

Identity

Trade Name
AN4000.61 EOGas 4 Ethylene Oxide Gas Sterilizer, 230V FDA UDI
Generic Name
Ethylene oxide sterilizer FDA UDI
Device Name
EOGas 4 Sterilizer 3 & 6 Hour Cycle, 230V FDA UDI
Model / Reference
AN4000.61 FDA UDI
Description
EOGas 4 Sterilizer 3 & 6 Hour Cycle, 230V FDA UDI

Identifiers

Catalog Number
AN4000.61 FDA UDI
Primary DI / UDI-DI
05060485030713 FDA UDI
510(k) Number
K192978 FDA UDI
FDA Product Code
FLF FDA UDI
GMDN Term
Ethylene oxide sterilizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6860 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

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

Yes

FDA UDI

Category: Ethylene oxide sterilizer

AN4000.61 EOGas 4 Ethylene Oxide Gas Sterilizer, 230V by Andersen Sterilizers, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ethylene oxide sterilizer.

Cleared under the same submission

K192978 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Andersen Sterilizers, Inc.

Sources (1)

  • FDA UDI b6d1fcd6-fb99-4739-9e84-d9cb308ac24b 35 fields · synced Jun 1, 2026