CryoSC-S Freezing Bag

Primary DI
07640125650372
Brand
CryoSC-S Freezing Bag
Company
Biosafe S.A.
Model
FB-100.1
Catalog number
10023
Published
2017-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
07640125650372PackageGS124
07640125650365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640125650372076401256503727640125650372
07640125650365076401256503657640125650365

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41223652727info@biosafe.ch
+41848802810ordersch@cytiva.com

Regulatory Flags#

DUNS number
488052341
Device count
1
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
true
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
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
07640125650389CryoSC-D Freezing BagFB-100.2100322017-01-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640125650365CryoSC-S Freezing BagBiosafe S.A.OOF2017-01-13
07640125650389CryoSC-D Freezing BagBiosafe S.A.OOF2017-01-13
07640125650402CryoSC-Db 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