Spike Coupler

GUDID 10816203020021

Blood transfer set

Primary Device ID	10816203020021
NIH Device Record Key	175e83e0-c74b-4adf-af58-066419ba91e4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Spike Coupler
Version Model Number	2S-P20
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 Issuing Agency	Device ID
GS1	10816203020021 [Primary]
GS1	20816203020028 [Package] Package: Case [20 Units] In Commercial Distribution

KJG	Tube, Tissue Culture

Steralize Prior To Use	false
Device Is Sterile	true

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