EOGas 4 Refill Kit AN1004.01

GUDID 05060485030454

AN1004.01 EOGas 4 Refill Kit, CA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters, 16 Humidichips, 17 EOGas 4 sterilization bags

ANDERSEN STERILIZERS INC.

Ethylene oxide sterilizer
Primary Device ID05060485030454
NIH Device Record Keyca35f328-7b3f-486f-9a59-f8d7fb71fc18
Commercial Distribution StatusIn Commercial Distribution
Brand NameEOGas 4 Refill Kit
Version Model NumberAN1004.01
Catalog NumberAN1004.01
Company DUNS931853006
Company NameANDERSEN STERILIZERS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-523-1276
Emailcustomerservice@anpro.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060485030454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLFSterilizer, Ethylene-Oxide Gas

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-02
Device Publish Date2018-09-01

On-Brand Devices [EOGas 4 Refill Kit]

05060485030454AN1004.01 EOGas 4 Refill Kit, CA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters, 16 Humidichips,
05060485030447AN1004.16 EOGas 4 Refill Kit, IATA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters, 16 Humidichips

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