ThermoGenesis AXP 80056

GUDID 00886368000612

AXP II Device

Thermogenesis Corp.

Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit

• Primary Device ID: 00886368000612
• NIH Device Record Key: 2fddeb07-43cb-48d6-b556-3889f2fa3414
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoGenesis AXP
• Version Model Number: 80056
• Catalog Number: 80056
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com
• Phone: 9168585100
• Email: customersupport@thermogenesis.com

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	00886368000001 [Primary]
GS1	00886368000612 [Direct Marking]
GS1	10886368000619 [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: 2023-09-22AXP II Device
• 00886368000612 - ThermoGenesis AXP: 2023-09-22 AXP II Device
• 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