QC Bagset 8-5110

GUDID 20886368000326

Utilized for quality control testing of the AXP Device.

CESCA THERAPEUTICS INC.

Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container

• Primary Device ID: 20886368000326
• NIH Device Record Key: 7cb61118-52a3-4fbb-ac1b-ea365af6ad77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QC Bagset
• Version Model Number: 70176
• Catalog Number: 8-5110
• 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 to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *15 deg C to 30 deg C, Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886368000322 [Primary]
GS1	10886368000329 [Package]; Contains: 00886368000322; Package: Case [10 Units]; In Commercial Distribution
GS1	20886368000326 [Package]; Contains: 10886368000329; Package: Pallet [4 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: false

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.

• 10886368000312 - MXP Processing Bagset: 2019-04-09 Cell separation processing and collection bag set.
• 00886368000353 - MXP Device: 2019-04-09 Cell separation processing device
• 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: 2018-07-06 Cord blood processing system and storage container
• 20886368000326 - QC Bagset: 2018-07-06Utilized for quality control testing of the AXP Device.
• 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