PrepaCyte-CB 500

GUDID 00861880000333

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

CRYO-CELL INTERNATIONAL, INC.

Blood centrifugation system containment kit
Primary Device ID00861880000333
NIH Device Record Key266e14c0-2ba2-4d2c-88a2-05f1d8034f73
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrepaCyte-CB 500
Version Model NumberPCB500
Company DUNS626132575
Company NameCRYO-CELL INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com
Phone8137492100
Emailprepacytecustomerservice@cryo-cell.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100861880000333 [Primary]

FDA Product Code

OAOCord Blood Processing System And Storage Container

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-31
Device Publish Date2022-01-21

Devices Manufactured by CRYO-CELL INTERNATIONAL, INC.

00861880000333 - PrepaCyte-CB 5002022-01-31The 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
00861880000333 - PrepaCyte-CB 5002022-01-31 The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total n
00861880000340 - Newborn Stem Cell Collection Kit Private kit2019-10-15 Newborn Stem Cell Collection Kit for private collection usage
00861880000357 - Newborn Stem Cell Collection Kit Public Kit2019-09-26 Newborn Stem Cell Collection Kit for Public collection usage.
00861880000364 - Newborn Stem Cell Collection Kit International Kit2019-09-26 Newborn Stem Cell Collection Kit for International collection usage.
00861880000302 - PrepaCyte-CB2018-03-29 Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to proc
00861880000319 - PrepaCyte-CB2018-03-29 Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to proc
00861880000326 - PrepaCyte-CB2018-03-29 The PrepaCyte CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total n

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