ThermoGenesis AutoXpress 80055

GUDID 00886368000667

AXP II Docking Station

Thermogenesis Corp.

Blood centrifugation system containment kit

• Primary Device ID: 00886368000667
• NIH Device Record Key: be803424-310f-4bbe-8287-c333a2695514
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoGenesis AutoXpress
• Version Model Number: 80055
• Catalog Number: 80055
• Company DUNS: 080690327
• Company Name: Thermogenesis Corp.
• 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: 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886368000667 [Direct Marking]
GS1	10886368000664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK180198

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-22
• Device Publish Date: 2023-09-14

Devices Manufactured by Thermogenesis Corp.

• 00886368000612 - ThermoGenesis AXP: 2023-09-22 AXP II Device
• 00886368000667 - ThermoGenesis AutoXpress: 2023-09-22AXP II Docking Station
• 00886368000667 - ThermoGenesis AutoXpress: 2023-09-22 AXP II Docking Station
• 00886368000285 - AXP Freezing Bag Set: 2023-09-21 Freezing Bag Set
• 00886368000605 - PXP: 2021-10-15 PXP Disposable Cartridge
• 00886368000148 - 3D Bag Set: 2021-10-12 3D Bag Set
• 00886368000551 - Thermogenesis Start Up Accessory Kit, MarrowXpress: 2021-10-12 Thermogenesis Start Up Accessory Kit, MarrowXpress
• 00886368000742 - X-LAB: 2021-10-12 X-LAB Docking Station
• 00886368000858 - X-Balance Ring Kit: 2021-10-12 X-Balance Ring Kit