3D Bag Set

GUDID 00886368000148

3D Bag Set

Thermogenesis Corp.

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: 00886368000148
• NIH Device Record Key: 536a33bc-0029-4243-96c4-5103ed9dc618
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Bag Set
• Version Model Number: 80105
• Company DUNS: 080690327
• Company Name: Thermogenesis Corp.
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886368000131 [Unit of Use]
GS1	00886368000148 [Primary]

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Sterilization

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

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

[00886368000148]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-12
• Device Publish Date: 2021-10-04

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: 2021-10-123D Bag Set
• 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