FDA.reportPublic FDA data

PrepaCyte-CB 500

Primary DI
00861880000333
Brand
PrepaCyte-CB 500
Company
CRYO-CELL INTERNATIONAL, INC.
Model
PCB500
Device description
The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total nucleated cells (TNC) from human umbilical cord blood
Published
2022-01-21
Public version status
New
Distribution status
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
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
00861880000333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861880000333008618800003338618800003330861880000333

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 Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8137492100prepacytecustomerservice@cryo-cell.com

Regulatory Flags#

DUNS number
626132575
Device count
1
Kit
true
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
00861880000340Newborn Stem Cell Collection Kit Private kitPrivate kit2019-10-07
00861880000357Newborn Stem Cell Collection Kit Public KitPublic Kit2019-09-18
00861880000364Newborn Stem Cell Collection Kit International KitInternational Kit2019-09-18
00861880000302PrepaCyte-CBPCB1100P/N PCB11002016-10-21
00861880000319PrepaCyte-CBPCB150P/N PCB1502016-10-21
00861880000326PrepaCyte-CBPCB2100-270P/N PCB2100-2702016-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886368000619ThermoGenesis AXPThermogenesis Corp.OAO2023-09-14
10886368000664ThermoGenesis AutoXpressThermogenesis Corp.OAO2023-09-14
00886368000001ThermoGenesis AXPThermogenesis Corp.OAO2023-09-14
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
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
00886368000629PXPThermogenesis Corp.OAO2021-09-29