Accessory Sets

GUDID 20816203023043

12ml syringe on a female luer with 15cm sealed SCD tubing

ORIGEN BIOMEDICAL, INC.

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• Primary Device ID: 20816203023043
• NIH Device Record Key: 6b6d1f3d-e9eb-4783-a04c-c6bcc8fffc05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accessory Sets
• Version Model Number: 15-RF12-T
• Company DUNS: 625272232
• Company Name: ORIGEN BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816203023046 [Primary]
GS1	20816203023043 [Package]; Contains: 10816203023046; Package: Case [25 Units]; In Commercial Distribution

FDA Product Code

• KJG: Tube, Tissue Culture

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-02-19
• Device Publish Date: 2016-09-23

On-Brand Devices [Accessory Sets]

• 20816203023067: One 0.2um filter to sealed SCD tubing, sterile
• 20816203023050: 20ml syringe on a female luer with 15cm sealed SCD tubing
• 20816203023043: 12ml syringe on a female luer with 15cm sealed SCD tubing