AN1036.00 Dosimeter, 14 Units EOG4 3&6 Hour Exposure AN1036.00

GUDID 05060485030683

Indicator, sterilization process, 14 count

ANDERSEN STERILIZERS INC.

Chemical/physical sterilization process indicator
Primary Device ID05060485030683
NIH Device Record Key122c77a8-219d-4fbe-bb40-086f9552852f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAN1036.00 Dosimeter, 14 Units EOG4 3&6 Hour Exposure
Version Model NumberAN1036.00
Catalog NumberAN1036.00
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 Kitfalse
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060485030683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOJIndicator, Physical/Chemical Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-08
Device Publish Date2023-08-31

Devices Manufactured by ANDERSEN STERILIZERS INC.

05060485030683 - AN1036.00 Dosimeter, 14 Units EOG4 3&6 Hour Exposure2023-09-08Indicator, sterilization process, 14 count
05060485030683 - AN1036.00 Dosimeter, 14 Units EOG4 3&6 Hour Exposure2023-09-08 Indicator, sterilization process, 14 count
05060485030706 - AN4000.60 EOGas 4 Ethylene Oxide Gas Sterilizer, 115V2023-09-08 EOGas 4 Sterilizer with 3 & 6 hour cycle options, 115V
05060485030713 - AN4000.61 EOGas 4 Ethylene Oxide Gas Sterilizer, 230V2023-09-08 EOGas 4 Sterilizer 3 & 6 Hour Cycle, 230V
05060485030737 - AN4000.66 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 120V2023-09-08 EOGas 4 Sterilizer 3 & 6 hour cycle Stainless Steel Cabinet, 120V
05060485030744 - AN4000.67 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 230V2023-09-08 EOGas 4 Sterilizer 3 & 6 hour cycle, stainless steel cabinet, 230V
05060485030607 - Anprolene AN75 Ethylene Oxide Sterilizer2020-08-24 AN75.64 - Anprolene AN75 Sterilizer, 115V
05060485030614 - Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V2020-08-24 AN75.65 - Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V
05060485030621 - Anprolene AN75 Ethylene Oxide Sterilizer, 115V2020-08-24 Anprolene AN75 Ethylene Oxide Sterilizer, 115V

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