X- Mixer

GUDID 00886368000025

X-Mixer

Thermogenesis Corp.

Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit
Primary Device ID00886368000025
NIH Device Record Keye0f9f261-9678-4d85-aa15-8865f96d974b
Commercial Distribution StatusIn Commercial Distribution
Brand NameX- Mixer
Version Model Number80095
Company DUNS080690327
Company NameThermogenesis Corp.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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

Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com
Phone9168585100
Emailcustomerservice@thermogenesis.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100886368000018 [Direct Marking]
GS100886368000025 [Primary]

FDA Product Code

LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.