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EOGas 4 Ethylene Oxide Gas Sterilizer

FDA UDI

Class II (US FDA UDI)

by Andersen Sterilizers, Inc.

Identity

Trade Name
EOGas 4 Ethylene Oxide Gas Sterilizer FDA UDI
Generic Name
Ethylene oxide sterilizer FDA UDI
Device Name
AN4000.11 EOGas 4 Ethylene Oxide Gas Sterilizer, 230V FDA UDI
Model / Reference
AN4000.11 FDA UDI
Description
AN4000.11 EOGas 4 Ethylene Oxide Gas Sterilizer, 230V FDA UDI

Identifiers

Catalog Number
AN4000.11 FDA UDI
Primary DI / UDI-DI
05060485030409 FDA UDI
510(k) Number
K150646 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Ethylene oxide sterilizer

EOGas 4 Ethylene Oxide Gas Sterilizer 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

K150646 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 36e10333-10b1-45a2-b920-3836cf999059 36 fields · synced Jun 1, 2026