FDA.reportPublic FDA data

Kit Connector

Primary DI
07640125650440
Brand
Kit Connector
Company
Biosafe S.A.
Model
Kit Connector
Catalog number
7033
Published
2016-09-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OAOCord Blood Processing System And Storage Container

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAOCord Blood Processing System And Storage ContainerHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640125650440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640125650440076401256504407640125650440

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41223652727support.biosafe@ge.com
+41848802810ordersch@cytiva.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640125650013Sterile Sampling LineAK-100100102017-01-13
07640125650037Sterile Sampling LineAK-101100282016-09-18
07640125650136Sepax single-use kitCS-530.1100152016-09-18
07640125650174Stem Cell Banking-Single-use kitsCS-530.4b100362016-09-18
07640125650211Stem Cell Banking-Single-use kitsCS-540.4b100372016-09-18
07640125650280Regenerative medicine-Single-use kitsCS-600.1100062017-01-13
07640125650303Regenerative medicine-Single-use kitsCS-900.2100082017-01-13
07640125650327DMSO Extension LineFA-100.1100222017-01-13
07640125650532Metal Storage CanisterMetal Storage Canister70122016-09-18
07640125650051Stem Cell Banking-Single-use kitsCS-430.1100172016-09-18
07640125650112Sepax single-use kitCS-490.1100012016-09-18
07640125650426Sample CalibratorSample Calibrator 0.3 ml60752016-09-18
07640125650433Sample CalibratorSample Calibrator 0.8 ml60742016-09-18
07640125650457Separation Chamber HolderSeparation Chamber Holder60332016-09-18
07640125650518Overwrap BagOverwrap Bag40852016-09-18
07640125650570CryoSC-Db Seal positionerCryoSC-Db Seal positioner70352016-09-18
07640125650587Sepax 2Sepax 2 S-100140002016-09-18
07640125650594Sepax RMSepax RM141002016-09-18
07640125650150Stem Cell Banking-Single-use kitsCS-530.4100242016-09-18
07640125650198Stem Cell Banking-Single-use kitsCS-540.4100252016-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00886368000612ThermoGenesis AXPThermogenesis Corp.OAO2023-09-14
00886368000667ThermoGenesis AutoXpressThermogenesis Corp.OAO2023-09-14
00886368000292AXP Freezing Bag SetThermogenesis Corp.OAO2023-09-13
00886368000285AXP Freezing Bag SetThermogenesis Corp.OAO2023-09-13
00861880000333PrepaCyte-CB 500CRYO-CELL INTERNATIONAL, INC.OAO2022-01-21
00886368000711PXPThermogenesis Corp.OAO2021-10-07
00886368000605PXPThermogenesis Corp.OAO2021-10-07
00886368000964PXPThermogenesis Corp.OAO2021-10-04
00886368001015PXPThermogenesis Corp.OAO2021-10-04
00886368000155PXPThermogenesis Corp.OAO2021-10-04
00886368000056PXP-1000Thermogenesis Corp.OAO2021-10-01
00886368000193PXP-LAVAREThermogenesis Corp.OAO2021-10-01
00886368000209PXP-LAVAREThermogenesis Corp.OAO2021-10-01
00886368000216PXP-LAVAREThermogenesis Corp.OAO2021-10-01
00886368000223PXP-LAVAREThermogenesis Corp.OAO2021-10-01
00886368000582Thermogenesis BioArchiveThermogenesis Corp.OAO2021-10-01
00886368000971PXPThermogenesis Corp.OAO2021-10-01
00886368000117PXP-1000Thermogenesis Corp.OAO2021-09-29
00886368000636PXPThermogenesis Corp.OAO2021-09-29
00886368000650PXPThermogenesis Corp.OAO2021-09-29
00886368000070PXP-1000 Docking StationThermogenesis Corp.OAO2021-09-29
00886368000094PXP-1000Thermogenesis Corp.OAO2021-09-29
00886368000100PXP-1000Thermogenesis Corp.OAO2021-09-29
00886368000087PXP-1000Thermogenesis Corp.OAO2021-09-29
00886368000124PXP-1000Thermogenesis Corp.OAO2021-09-29
00886368000186PXP-LAVAREThermogenesis Corp.OAO2021-09-29
00886368000544Thermogenesis Start Up Accessory Kit, AXPThermogenesis Corp.OAO2021-09-29