Cryostore Harvest Kit

GUDID 10816203020526

Cryostore Harvest Kit, 750 EVA Freezing Bag, "Y12" Tubing Set, case of 12, double packed

ORIGEN BIOMEDICAL, INC.

Blood/tissue storage/culture container
Primary Device ID10816203020526
NIH Device Record Keyb0bc9b37-8c8f-456b-8985-6de30247a3b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCryostore Harvest Kit
Version Model NumberCS750Y12S
Company DUNS625272232
Company NameORIGEN BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
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
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110816203020526 [Primary]
GS120816203020523 [Package]
Package: Case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-06-17
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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