FDA.reportPublic FDA data

CryoSC-D Freezing Bag

Primary DI
07640125650389
Brand
CryoSC-D Freezing Bag
Company
Biosafe S.A.
Model
FB-100.2
Catalog number
10032
Published
2017-01-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOFCryogenic Cord Blood Storage Container

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOFCryogenic Cord Blood Storage ContainerHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0900370

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0900370

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
7640125650396PackageGS124Not in Commercial Distribution
07640125650389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
7640125650396076401256503967640125650396
07640125650389076401256503897640125650389

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA receptacle 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. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+41848802810ordersch@cytiva.com

Regulatory Flags#

DUNS number
488052341
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640125650150Stem Cell Banking-Single-use kitsCS-530.4100242016-09-18
07640125650198Stem Cell Banking-Single-use kitsCS-540.4100252016-09-18
07640125650440Kit ConnectorKit Connector70332016-09-18
07640125650488Press ModularPress Modular70402016-09-18
07640125650495Traceability Labels for cryopreservationTraceability Labels for cryopreservation70112016-09-18
07640125650501Traceability Labels for BioarchiveTraceability Labels for Bioarchive70312016-09-18
07640125650556Insertion ToolInsertion Tool70302016-09-18
07640125650075Regenerative medicine-Single-use kitsCS-470.0100342016-09-18
07640125650099Sepax single-use kitCS-470.1100052016-09-18
07640125650259Stem Cell Banking-Single-use kitsCS-570.4100302017-01-13
07640125650341Double Spike AccessoryFA-200.1100432017-01-13
07640125650365CryoSC-S Freezing BagFB-100.1100232017-01-13
07640125650402CryoSC-Db Freezing BagFB-100.2b100412017-01-13
07640125650273Stem Cell Banking-Single-use kitsCS-570.4mb100392016-09-18
07640125650563CryoSC-D Seal positionerCryoSC-D Seal positioner70262016-09-18
07640125650532Metal Storage CanisterMetal Storage Canister70122016-09-18
07640125650570CryoSC-Db Seal positionerCryoSC-Db Seal positioner70352016-09-18
07640125650457Separation Chamber HolderSeparation Chamber Holder60332016-09-18
07640125650464DMSO Vial Adaptator 7 mlDMSO Vial Adaptator 7 ml60762016-09-18
07640125650471DMSO Vial Adaptator 8 mlDMSO Vial Adaptator 8 ml60892016-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640125650365CryoSC-S Freezing BagBiosafe S.A.OOF2017-01-13
07640125650402CryoSC-Db Freezing BagBiosafe S.A.OOF2017-01-13
07640125650372CryoSC-S Freezing BagBiosafe S.A.OOF2017-01-13
7640125650396CryoSC-D Freezing BagBiosafe S.A.OOF2017-01-13
07640125650419CryoSC-Db Freezing BagBiosafe S.A.OOF2017-01-13