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 ID: 00861880000302
• NIH Device Record Key: fed00899-c95d-4cff-8cf0-bd0604aaf805
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PrepaCyte-CB
• Version Model Number: PCB1100
• Catalog Number: P/N PCB1100
• Company DUNS: 626132575
• Company Name: CRYO-CELL INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8137492188
• Email: prepacytecustomerservice@cryo-cell.com

Device Dimensions

• Length: 8.84 Centimeter
• Length: 8.84 Centimeter
• Length: 8.84 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861880000302 [Primary]

FDA Product Code

• OAO: Cord Blood Processing System And Storage Container

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-21

On-Brand Devices [PrepaCyte-CB]

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