FDA.reportPublic FDA data

CryoStore

Primary DI
20816203023555
Brand
CryoStore
Company
ORIGEN BIOMEDICAL, INC.
Model
CS20N
Catalog number
CS20N
Device description
CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "N" Tube Set
Published
2021-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSRContainer, Empty, For Collection & Processing Of Blood & Blood ComponentsHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1802780

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1802780

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816203023555PackageGS16In Commercial Distribution
10816203023558PrimaryGS10
00816203023551Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081620302355520816203023555
1081620302355810816203023558
00816203023551008162030235518162030235510816203023551

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA durable, sterile plastic container with ports, or glass bottle, intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. The device provides a suitable closed environment to reduce the risk of contamination and, if applicable, for cell growth/viability during storage that may or may not involve freezing. A device intended for cryopreservation is typically designed for long-term storage in a freezing system. A device intended for culture is typically gas permeable and may have an inner surface that enables adherence. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not re-use
Special Storage Condition, Specify00Do not resterilize
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
512-474-7278regulatory@origenbio.com
+1-512-474-7278regulatory@origenbio.com

Regulatory Flags#

DUNS number
625272232
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816203023848AccessoriesVSVVSV2025-06-18
10816203023916O-Wrap™ BagOW0909OW09092025-06-18
10816203024012TissueVault™ Cell & Tissue Freezing BagTV0909TV09092025-06-18
10816203024074Evolve Cell Culture BagEV120 + F-M12EV120 + F-M122025-06-18
10816203024098O-Wrap™ BagOW0918OW09182025-06-18
10816203024159TissueVault™ Cell & Tissue Freezing BagTV0918TV09182025-06-18
10816203023923PermaLife™ Cell Culture BagPL07-2GPL07-2G2025-06-18
10816203023930PermaLife™ Cell Culture BagPL30-2GPL30-2G2025-06-18
10816203024104PermaLife™ Cell Culture BagPL30MPL30M2025-06-18
10816203024128PermaLife™ Cell Culture BagPL70-2GPL70-2G2025-06-18
10816203024340PermaLife™ Cell Culture BagPL120NPL120N2025-06-18
10816203024357PermaLife™ Cell Culture BagPL120-2GPL120-2G2025-06-18
10816203023855Accessories15-R3FT15-R3FT2025-06-18
10816203023862Accessories15-R6F-TA15-R6F-TA2025-06-18
10816203023879Accessories15-RF12-T15-RF12-T2025-06-18
10816203023886Accessories15-RF20-T15-RF20-T2025-06-18
10816203023947AccessoriesR3F-T15R3F-T152025-06-18
10816203023961AccessoriesS-F10S-F102025-06-18
10816203023978AccessoriesS-F50S-F502025-06-18
10816203023985AccessoriesS-FFP12S-FFP122025-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30812747019815Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONKSR2025-07-16
00812747019814Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONKSR2025-07-16
10816203023909CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024050CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024067CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024203CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024210CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024227CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024234CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024241CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024258CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024289CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024302CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024319CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203023906CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024057CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024064CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024200CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024217CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024224CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024231CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024248CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024255CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024286CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024309CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024316CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
00810020441741Adaptive Nomogram BottleFresenius Kabi AGKSR2025-03-14
10810020441748Adaptive Nomogram BottleFresenius Kabi AGKSR2025-03-14
00810020441383Plasmalink Bottle 1000 mL with locking luer adapterFresenius Kabi AGKSR2025-01-15
10810020441380Plasmalink Bottle 1000 mL with locking luer adapterFresenius Kabi AGKSR2025-01-15