Tube Set

GUDID 20816203022183

RBC tube set, sealed tube with spike, FLL, and spike port

ORIGEN BIOMEDICAL, INC.

Blood transfer set
Primary Device ID20816203022183
NIH Device Record Keyba812b4a-f6aa-413a-a2c2-1e69778bed25
Commercial Distribution Discontinuation2024-12-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTube Set
Version Model Number30-T-SPF
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
GS110816203022186 [Primary]
GS120816203022183 [Package]
Contains: 10816203022186
Package: Case [12 Units]
Discontinued: 2024-12-12
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 Date2024-12-13
Device Publish Date2016-09-23

Devices Manufactured by ORIGEN BIOMEDICAL, INC.

20816203021100 - CryoStore Freezing Bag2024-12-16 CryoStore 30 EVA Multi-Chamber Freezing Bag, 30ml, "M9" Tube Set
20816203022824 - Accessories2024-12-16 One 60ml syringe with one 0.22um filter and one 5um filter Single aseptically pouched
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
10816203023664 - PermaLife™ Cell Culture Bag2024-12-16 PermaLife Cell Culture Bag, 70ml, "K" Set
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
10816203023695 - PermaLife™ Cell Culture Bag2024-12-16 PermaLife Cell Culture Bag, 750ml, "K" Set

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