Spike Adapter

GUDID 10816203020632

One spike to a needle-free valve to one spike and two male luers with 40cm tubing and roller clamps

ORIGEN BIOMEDICAL, INC.

Blood transfer set

• Primary Device ID: 10816203020632
• NIH Device Record Key: 62d24320-6b1c-4282-b263-ac95c9709077
• Commercial Distribution Discontinuation: 2024-12-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Spike Adapter
• Version Model Number: 40-S-V-SMM
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816203020632 [Primary]
GS1	20816203020639 [Package]; Package: Case [20 Units]; Discontinued: 2024-12-12; 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: 2024-12-13
• Device Publish Date: 2016-09-23

On-Brand Devices [Spike Adapter]

• 10816203022469: One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
• 10816203022384: One spike to one spike with 10cm of SCD tubing and pinch clamp, case of 50
• 10816203021967: One spike with male to male luer, case of 50
• 10816203021936: One spike to one spike with 50cm of SCD tubing and pinch clamp, case of 50
• 10816203021929: One spike to one female luer with 15cm DMSO resistant tubing and pinch clamp, case of 50
• 10816203021912: One spike to one 3/8" barb with 12cm DMSO resistant tubing
• 10816203020588: One spike to one male luer with 150cm tubing and roller clamp
• 10816203020274: One spike to 1 male luer w/50cm SCD tubing & roller clamp
• 20816203020264: One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
• 10816203020250: One spike to one male luer with 10cm DMSO resistant tubing and pinch clamp, case of 50
• 10816203020243: One spike to one female luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
• 10816203020236: One spike to one female luer with 10cm DMSO resistant tubing and pinch clamp, case of 50
• 10816203020632: One spike to a needle-free valve to one spike and two male luers with 40cm tubing and roller cla