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 ID: 05060485030683
• NIH Device Record Key: 122c77a8-219d-4fbe-bb40-086f9552852f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AN1036.00 Dosimeter, 14 Units EOG4 3&6 Hour Exposure
• Version Model Number: AN1036.00
• Catalog Number: AN1036.00
• Company DUNS: 931853006
• Company Name: ANDERSEN STERILIZERS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060485030683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200334

FDA Product Code

• JOJ: Indicator, Physical/Chemical Sterilization Process

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-08
• Device Publish Date: 2023-08-31

Devices Manufactured by ANDERSEN STERILIZERS INC.

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• 05060485030683 - AN1036.00 Dosimeter, 14 Units EOG4 3&6 Hour Exposure: 2023-09-08 Indicator, sterilization process, 14 count
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• 05060485030744 - AN4000.67 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 230V: 2023-09-08 EOGas 4 Sterilizer 3 & 6 hour cycle, stainless steel cabinet, 230V
• 05060485030607 - Anprolene AN75 Ethylene Oxide Sterilizer: 2020-08-24 AN75.64 - Anprolene AN75 Sterilizer, 115V
• 05060485030614 - Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V: 2020-08-24 AN75.65 - Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V
• 05060485030621 - Anprolene AN75 Ethylene Oxide Sterilizer, 115V: 2020-08-24 Anprolene AN75 Ethylene Oxide Sterilizer, 115V