AXP Disposable Processing Bagset

GUDID 10886368000305

Cord blood processing system and storage container

CESCA THERAPEUTICS INC.

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• Primary Device ID: 10886368000305
• NIH Device Record Key: 62d507a8-f0ab-4595-a2c2-2ccfa4eb48d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AXP Disposable Processing Bagset
• Version Model Number: 8-5101
• Company DUNS: 175719335
• Company Name: CESCA THERAPEUTICS 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com
• Phone: 916-858-5100
• Email: customerservice@cescatherapeutics.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C - 30 deg C, Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886368000308 [Primary]
GS1	10886368000305 [Package]; Contains: 00886368000308; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK070006

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by CESCA THERAPEUTICS INC.

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• 00886368000384 - MXP Docking Station: 2019-04-09 Cell separation processing, docking station
• 00886368000391 - MXP Start Up Kit: 2019-04-09 Startup kit for the MXP System
• 10886368000305 - AXP Disposable Processing Bagset: 2018-07-06Cord blood processing system and storage container
• 10886368000305 - AXP Disposable Processing Bagset: 2018-07-06 Cord blood processing system and storage container
• 20886368000326 - QC Bagset: 2018-07-06 Utilized for quality control testing of the AXP Device.
• 00886368000346 - AXP Device: 2018-07-06 Cord blood processing system
• 00886368000360 - AXP Docking Station: 2018-07-06 Cord blood processing system docking station