Anprolene AN75 Ethylene Oxide Sterilizer, 115V AN75.74

GUDID 05060485030621

Anprolene AN75 Ethylene Oxide Sterilizer, 115V

ANDERSEN STERILIZERS INC.

Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer
Primary Device ID05060485030621
NIH Device Record Key757c76d9-4769-43ee-ab2a-5ecb0a6afc85
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnprolene AN75 Ethylene Oxide Sterilizer, 115V
Version Model NumberAN75.74
Catalog NumberAN75.74
Company DUNS931853006
Company NameANDERSEN STERILIZERS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS105060485030621 [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.

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, 115V2020-08-24Anprolene AN75 Ethylene Oxide Sterilizer, 115V
05060485030621 - Anprolene AN75 Ethylene Oxide Sterilizer, 115V2020-08-24 Anprolene AN75 Ethylene Oxide Sterilizer, 115V
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.