Auto Volume Expressor 8-4100-0

GUDID 00886368000506

Accessory to the BioArchive System

CESCA THERAPEUTICS INC.

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• Primary Device ID: 00886368000506
• NIH Device Record Key: 2c4134d2-32e2-4d98-9173-aa2bc54c0b54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Auto Volume Expressor
• Version Model Number: 8-4100-0
• Catalog Number: 8-4100-0
• Company DUNS: 175719335
• Company Name: CESCA THERAPEUTICS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886368000506 [Primary]
GS1	10886368000503 [Package]; Package: Box [1 Units]; In Commercial Distribution

FDA Product Code

• KSE: Refrigerator, Freezer, Blood Storage

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-05

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: 2018-07-06 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