Triple Spike Adapter

GUDID 10816203020625

Three spikes to sealed tubing with 100cm of SCD tubing and pinch clamps

ORIGEN BIOMEDICAL, INC.

Blood transfer set
Primary Device ID10816203020625
NIH Device Record Keyb8bf6848-65d0-4c4b-ac50-c982ef4ed64f
Commercial Distribution Discontinuation2024-12-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTriple Spike Adapter
Version Model Number3S-T100
Company DUNS625272232
Company NameORIGEN BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110816203020625 [Primary]
GS120816203020622 [Package]
Package: Case [12 Units]
Discontinued: 2024-12-11
Not in Commercial Distribution

FDA Product Code

KJGTube, Tissue Culture

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-12-12
Device Publish Date2016-09-23

Devices Manufactured by ORIGEN BIOMEDICAL, INC.

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20816203023449 - Accessories2024-12-16 6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing
10816203023657 - PermaLife™ Cell Culture Bag2024-12-16 PermaLife Cell Culture Bag, 30ml, "K" Set
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10816203023671 - PermaLife™ Cell Culture Bag2024-12-16 PermaLife Cell Culture Bag, 120ml, "K" Set
10816203023688 - PermaLife™ Cell Culture Bag2024-12-16 PermaLife Cell Culture Bag, 500ml, "K" Set
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