FDA.reportPublic FDA data

Regenerative medicine-Single-use kits

Primary DI
07640125650075
Brand
Regenerative medicine-Single-use kits
Company
Biosafe S.A.
Model
CS-470.0
Catalog number
10034
Published
2016-09-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640125650082PackageGS112Not in Commercial Distribution
07640125650075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640125650082076401256500827640125650082
07640125650075076401256500757640125650075

GMDN Terms#

Term, Definition table
TermDefinition
Blood centrifugation system containment kitA collection of sterile devices that is a component of a blood centrifugation system intended to be used during the centrifugation of blood, relative components or cellular products (e.g., umbilical cord blood, bone marrow), to automatically isolate constituent components (e.g., cells, plasma). The kit is not donor or patient connected and is placed in the centrifuge of the processing unit. It includes a centrifugation chamber into which blood is introduced and sedimented into its components during centrifugation, a stopcock manifold and tubing intended to direct and control the sequential movement of each component, and collection containers. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius40 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
488052341
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
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
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
07640125650471DMSO Vial Adaptator 8 mlDMSO Vial Adaptator 8 ml60892016-09-18

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