Getinge Assured MI Steam Migrating Integrator Strip

GUDID 30814434021231

STERITEC PRODUCT MFG. CO., INC.

Chemical/physical sterilization process indicator

• Primary Device ID: 30814434021231
• NIH Device Record Key: e9697639-c328-4651-a687-64a83371cbe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Getinge Assured MI Steam Migrating Integrator Strip
• Version Model Number: 61301606825
• 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: false
• 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	00814434021230 [Primary]
GS1	30814434021231 [Package]; Contains: 00814434021230; Package: Bag [250 Units]; In Commercial Distribution
GS1	40814434021238 [Package]; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200252

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: 2020-07-27
• Device Publish Date: 2020-07-17

Devices Manufactured by STERITEC PRODUCT MFG. CO., INC.

• 10814434020803 - SteriTec Green Tape 3/4": 2022-06-17
• 10814434021312 - SteriTec Green Tape 1": 2022-06-17
• 10814434021633 - Getinge Assured Green Tape 3/4": 2022-06-17
• 10814434021640 - Getinge Assured Green Tape 1": 2022-06-17
• 30814434021231 - Getinge Assured MI Steam Migrating Integrator Strip: 2020-07-27
• 30814434021231 - Getinge Assured MI Steam Migrating Integrator Strip: 2020-07-27
• 10732224109265 - Crosstex International: 2020-05-06 Sure Check Strip
• 20814434020619 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 13cm: 2019-11-08
• 20814434020626 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 23cm: 2019-11-08