Getinge Assure Chemisix Sterilization Emulator 61301606200

GUDID 10814434020407

STERITEC PRODUCT MFG. CO., INC.

Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator

• Primary Device ID: 10814434020407
• NIH Device Record Key: 5b544dc2-a634-4c09-a968-0121041578d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Getinge Assure Chemisix Sterilization Emulator
• Version Model Number: 61301606200
• Catalog Number: 61301606200
• Company DUNS: 622223196
• Company Name: STERITEC PRODUCT MFG. CO., 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	00814434020400 [Primary]
GS1	10814434020407 [Package]; Contains: 00814434020400; Package: Bag [250 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [Getinge Assure Chemisix Sterilization Emulator]

• 10814434020414: 61301606626
• 10814434020407: 61301606200