PrepaCyte-CB P/N PCB1100

GUDID 00861880000302

Indications for Use: 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, prior to banking. The device is composed of three integrally-attached processing and storage containers (or a single processing container) with separation media.

CRYO-CELL INTERNATIONAL, INC.

Blood centrifugation system containment kit
Primary Device ID00861880000302
NIH Device Record Keyfed00899-c95d-4cff-8cf0-bd0604aaf805
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrepaCyte-CB
Version Model NumberPCB1100
Catalog NumberP/N PCB1100
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8137492188
Emailprepacytecustomerservice@cryo-cell.com

Device Dimensions

Length8.84 Centimeter
Length8.84 Centimeter
Length8.84 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100861880000302 [Primary]

FDA Product Code

OAOCord Blood Processing System And Storage Container

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-21

On-Brand Devices [PrepaCyte-CB]

00861880000326The PrepaCyte CB (Cord Blood) Processing System is intended for use in cell processing laborator
00861880000319Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell
00861880000302Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell

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