Anprolene AN75 Refill Kit, 14 Units AN7514.00

GUDID 05060485030669

Anprolene AN75 Refill Kit, 14 Units - 14 EO 17.6g cartridges, 14 AN87 Dosimeters, 15 AN75 liner bags

ANDERSEN STERILIZERS INC.

Ethylene oxide sterilizer
Primary Device ID05060485030669
NIH Device Record Keyddf3cdec-f5bd-44e4-9702-023e29d2de29
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnprolene AN75 Refill Kit, 14 Units
Version Model NumberAN7514.00
Catalog NumberAN7514.00
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

Customer Support Contacts

Phone800-523-1276
Emailcustomerservice@sterility.com
Phone800-523-1276
Emailcustomerservice@sterility.com
Phone800-523-1276
Emailcustomerservice@sterility.com
Phone800-523-1276
Emailcustomerservice@sterility.com
Phone800-523-1276
Emailcustomerservice@sterility.com
Phone800-523-1276
Emailcustomerservice@sterility.com
Phone800-523-1276
Emailcustomerservice@sterility.com
Phone800-523-1276
Emailcustomerservice@sterility.com
Phone800-523-1276
Emailcustomerservice@sterility.com
Phone800-523-1276
Emailcustomerservice@sterility.com
Phone800-523-1276
Emailcustomerservice@sterility.com
Phone800-523-1276
Emailcustomerservice@sterility.com
Phone800-523-1276
Emailcustomerservice@sterility.com
Phone800-523-1276
Emailcustomerservice@sterility.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060485030669 [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 Date2020-08-24
Device Publish Date2020-08-14

Devices Manufactured by ANDERSEN STERILIZERS INC.

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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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