TubeSet Adapter

GUDID 10816203020014

4x12cm SCD tubing tube set

ORIGEN BIOMEDICAL, INC.

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• Primary Device ID: 10816203020014
• NIH Device Record Key: fc9b88a8-8b40-4d18-9ed8-20c074867f42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TubeSet Adapter
• Version Model Number: 24-T-3T
• 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
• 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
• Phone: 512-474-7278
• Email: regulatory@origen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816203020014 [Primary]
GS1	20816203020011 [Package]; Package: Case [20 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 [TubeSet Adapter]

• 10816203022339: One spike to one female luer with 12cm SCD Tubing, case of 50
• 10816203020601: Two male luers to one male luer with 17cm of DMSO resistant tubing
• 10816203020595: Two male luers to one female luer with 17cm of DMSO resistant tubing
• 10816203020014: 4x12cm SCD tubing tube set
• 10816203022193: Adapter tube set, 4 bag spikes x 1 Male luer, 40cm