PXP

GUDID 00886368000629

PXP Control Module

Thermogenesis Corp.

Blood centrifugation system containment kit

• Primary Device ID: 00886368000629
• NIH Device Record Key: 15866b69-a8a0-48e9-9a62-d9f0f5a8e0ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PXP
• Version Model Number: 80065
• 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	00886368000629 [Direct Marking]
GS1	00886368000636 [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: 2021-10-07
• Device Publish Date: 2021-09-29

On-Brand Devices [PXP]

• 00886368000643: PXP Docking Station
• 00886368000629: PXP Control Module
• 00886368000971: PXP Disposable Cartridge
• 00886368000155: PXP Disposable Cartridge
• 00886368000605: PXP Disposable Cartridge