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ThermoGenesis Corp.

Matched from indexed company URL: Thermogenesis Corp.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29503741000123765ThermoGenesis Corp.1N2026-01-012890 Kilgore Rd RANCHO CORDOVA CA US 95670

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00886368000001ThermoGenesis AXP - AXP II Refurbished Device9168585100customersupport@thermogenesis.com
00886368000285AXP Freezing Bag Set - Freezing Bag Set9168585100customersupport@thermogenesis.com
00886368000292AXP Freezing Bag Set - Freezing Bag Set9168585100customersupport@thermogenesis.com
00886368000612ThermoGenesis AXP - AXP II Device9168585100customersupport@thermogenesis.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
516461814667406K081345AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)JQC2008-07-10
516461048984614BK980038
516461203489020BK980030
516461781182321BK980027
516461572274889BK180198
516461287621192BK120061
516461907423787BK110040
516461787063549BK100066
516461179799523BK070006
516461158263069
516461386222076
516461518804821
516461177858669
516461594597914

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JQC12008-07-10

PMN#

GUDID#

SynGen® DataTrak - The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC computer. It downloads processing and system information from the CM and stores it in a database on the host PC computer. The data collected includes information gathered during each buffy coat harvest run including output of the accelerometer, infrared sensor readings, and timing and duration of the pinch and release of the cell transfer tubes. This collected data serves to document each processing run of the cord blood to support cGMP compliance.

Thermogenesis Corp.

2016-09-24

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