Thermogenesis Start Up Accessory Kit, AXP

GUDID 00886368000544

Thermogenesis Start Up Accessory Kit, AXP

Thermogenesis Corp.

Blood centrifugation system containment kit

• Primary Device ID: 00886368000544
• NIH Device Record Key: 469b58d0-f16e-4b30-a311-8a79b4eb6d58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermogenesis Start Up Accessory Kit, AXP
• Version Model Number: 8-5100
• 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: true
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com
• Phone: 9168585100
• Email: customerservice@thermogenesis.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886368000544 [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: 2021-10-07
• Device Publish Date: 2021-09-29

Devices Manufactured by Thermogenesis Corp.

• 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