OriGen Biomedical CC3

GUDID 20816203023319

Four spikes to a 3-way stopcock, 60ml syringe and needle-free valve to four male luers with 70cm SCD tubing and pinch clamps.

ORIGEN BIOMEDICAL, INC.

Blood transfer set

• Primary Device ID: 20816203023319
• NIH Device Record Key: a12fbc56-aa70-4c79-afc9-4f4d7a0a047d
• Commercial Distribution Discontinuation: 2024-12-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OriGen Biomedical
• Version Model Number: CC3
• Catalog Number: CC3
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816203023312 [Primary]
GS1	20816203023319 [Package]; Contains: 10816203023312; Package: Case [12 Units]; Discontinued: 2024-12-11; Not 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: 2024-12-12
• Device Publish Date: 2017-10-12

Devices Manufactured by ORIGEN BIOMEDICAL, INC.

• 10816203023800 - Accessories: 2025-06-26 DMSO-Resistant Bag Spike with needle injection port
• 20816203023845 - Accessories: 2025-06-26 Needle-free vial spike, DMSO-resistant
• 20816203023852 - Accessories: 2025-06-26 3ml syringe on a female luer with 15cm of SCD tubing
• 20816203023869 - Accessories: 2025-06-26 6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing
• 20816203023876 - Accessories: 2025-06-26 12ml syringe on a female luer with 15cm sealed SCD tubing
• 20816203023883 - Accessories: 2025-06-26 20ml syringe on a female luer with 15cm sealed SCD tubing
• 20816203023906 - CryoStore Freezing Bag: 2025-06-26 CryoStore 25 EVA Freezing Bag, 10-25ml, "F" Tube Set, singly packed
• 20816203023913 - O-Wrap™ Bag: 2025-06-26 O-Wrap, overwrap pouch for freezing, 9x9cm