PXP-1000

GUDID 00886368000056

PXP-1000 Control Module

Thermogenesis Corp.

Blood centrifugation system containment kit

• Primary Device ID: 00886368000056
• NIH Device Record Key: d1479485-c966-4e64-a466-a0e3f28520b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PXP-1000
• Version Model Number: 80104
• 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: 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 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886368000049 [Direct Marking]
GS1	00886368000056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK120061

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: 2021-10-11
• Device Publish Date: 2021-10-01

On-Brand Devices [PXP-1000]

• 00886368000124: PXP-1000 Disposable Cartridge
• 00886368000087: PXP-1000 Disposable Cartridge
• 00886368000100: PXP-1000 Disposable Cartridge
• 00886368000056: PXP-1000 Control Module