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 ID: 00861880000333
• NIH Device Record Key: 266e14c0-2ba2-4d2c-88a2-05f1d8034f73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PrepaCyte-CB 500
• Version Model Number: PCB500
• 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: true
• 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: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com
• Phone: 8137492100
• Email: prepacytecustomerservice@cryo-cell.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861880000333 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-31
• Device Publish Date: 2022-01-21

Devices Manufactured by CRYO-CELL INTERNATIONAL, INC.

• 00861880000333 - PrepaCyte-CB 500: 2022-01-31The 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 500: 2022-01-31 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 kit: 2019-10-15 Newborn Stem Cell Collection Kit for private collection usage
• 00861880000357 - Newborn Stem Cell Collection Kit Public Kit: 2019-09-26 Newborn Stem Cell Collection Kit for Public collection usage.
• 00861880000364 - Newborn Stem Cell Collection Kit International Kit: 2019-09-26 Newborn Stem Cell Collection Kit for International collection usage.
• 00861880000302 - PrepaCyte-CB: 2018-03-29 Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to proc
• 00861880000319 - PrepaCyte-CB: 2018-03-29 Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to proc
• 00861880000326 - PrepaCyte-CB: 2018-03-29 The PrepaCyte CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total n