Thermogenesis BioArchive

GUDID 00886368000582

BioArchive Device 220V

Thermogenesis Corp.

Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer Ultralow-temperature laboratory freezer
Primary Device ID00886368000582
NIH Device Record Key4f535d42-d0a2-4f63-b8f8-04aeea8b4b47
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermogenesis BioArchive
Version Model Number8-4000-1
Company DUNS080690327
Company NameThermogenesis Corp.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com
Phone916-858-5100
Emailcustomerservice@thermogenesis.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100886368000582 [Primary]

FDA Product Code

OAOCord Blood Processing System And Storage Container

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-11
Device Publish Date2021-10-01

Devices Manufactured by Thermogenesis Corp.

00886368000612 - ThermoGenesis AXP2023-09-22 AXP II Device
00886368000667 - ThermoGenesis AutoXpress2023-09-22 AXP II Docking Station
00886368000285 - AXP Freezing Bag Set2023-09-21 Freezing Bag Set
00886368000605 - PXP2021-10-15 PXP Disposable Cartridge
00886368000148 - 3D Bag Set2021-10-12 3D Bag Set
00886368000551 - Thermogenesis Start Up Accessory Kit, MarrowXpress2021-10-12 Thermogenesis Start Up Accessory Kit, MarrowXpress
00886368000742 - X-LAB2021-10-12 X-LAB Docking Station
00886368000858 - X-Balance Ring Kit2021-10-12 X-Balance Ring Kit

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