Cell Conect

GUDID 20816203020066

One spike and male luer 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 ID20816203020066
NIH Device Record Key45cab86b-648e-43b2-9cc9-2b4154565145
Commercial Distribution StatusIn Commercial Distribution
Brand NameCell Conect
Version Model NumberCC2
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
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
GS110816203020069 [Primary]
GS120816203020066 [Package]
Contains: 10816203020069
Package: Case [12 Units]
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 Date2025-06-18
Device Publish Date2016-09-23

Devices Manufactured by ORIGEN BIOMEDICAL, INC.

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20816203023852 - Accessories2025-06-26 3ml syringe on a female luer with 15cm of SCD tubing
20816203023869 - Accessories2025-06-26 6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing
20816203023876 - Accessories2025-06-26 12ml syringe on a female luer with 15cm sealed SCD tubing
20816203023883 - Accessories2025-06-26 20ml syringe on a female luer with 15cm sealed SCD tubing
20816203023906 - CryoStore Freezing Bag2025-06-26 CryoStore 25 EVA Freezing Bag, 10-25ml, "F" Tube Set, singly packed
20816203023913 - O-Wrap™ Bag2025-06-26 O-Wrap, overwrap pouch for freezing, 9x9cm

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