AN1087 Dosimeter, Chemical Indicator AN1087.00

GUDID 05060485030294

AN1087.00 Dosimeter, Chemical Indicator, 25 units

ANDERSEN STERILIZERS INC.

Chemical/physical sterilization process indicator

• Primary Device ID: 05060485030294
• NIH Device Record Key: ffaa0723-c44b-4812-ab6c-8d131b418e8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AN1087 Dosimeter, Chemical Indicator
• Version Model Number: AN1087.00
• Catalog Number: AN1087.00
• Company DUNS: 931853006
• Company Name: ANDERSEN STERILIZERS INC.
• Device Count: 25
• 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: true

Customer Support Contacts

• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com
• Phone: 800-523-1276
• Email: customerservice@anpro.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060485030294 [Primary]
GS1	05060485030485 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150645

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: 2018-10-02
• Device Publish Date: 2018-09-01

On-Brand Devices [AN1087 Dosimeter, Chemical Indicator]

• 05060485030423: AN1087.16 Dosimeter, Chemical Indicator, 16 units
• 05060485030294: AN1087.00 Dosimeter, Chemical Indicator, 25 units