AccessGUDID - DEVICE: EOGas 4 Refill Kit (05060485030164)

GUDID

Device Identifier (DI) Information

Brand Name: EOGas 4 Refill Kit
Version or Model: AN1004.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AN1004.00
Company Name: ANDERSEN STERILIZERS INC.

Primary DI Number: 05060485030164
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 931853006 *Terms of Use

Device Description: AN1004.00 EOGas 4 Refill Kit, 25 EO 17.6g cartridges, 25 AN1087 Dosimeters, 25 Humidichips, 26 EOGas 4 sterilization bags

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13740	Ethylene oxide sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using ethylene oxide (ETO) gas with low humidity content as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris and packed in gas permeable wraps; a means to introduce the gas into the chamber; and controls to chose one of the sterilization cycles. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLF	Sterilizer, Ethylene-Oxide Gas

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150646	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b0811fb5-9ea5-4a39-8e6c-3b99be5ccbba
Public Version Date: October 02, 2018
Public Version Number: 1
DI Record Publish Date: September 01, 2018