X-LAB

GUDID 00886368000674

X-LAB Disposable Cartridge

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 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 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 ID00886368000674
NIH Device Record Key51849f70-edc5-4a7b-91a5-e28dd10f6f2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-LAB
Version Model Number80060
Company DUNS080690327
Company NameThermogenesis Corp.
Device Count36
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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
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
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
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
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
GS100886368000674 [Unit of Use]
GS100886368000681 [Primary]
GS100886368000926 [Primary]
GS100886368001022 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


[00886368000674]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-07
Device Publish Date2021-09-29

On-Brand Devices [X-LAB]

00886368000674X-LAB Disposable Cartridge
00886368000933X-LAB Disposable Cartridge
00886368000728X-LAB Control Module
00886368000988X-LAB Kit
00886368000742X-LAB Docking Station

Trademark Results [X-LAB]

Mark Image

Registration | Serial
Company
Trademark
Application Date
X-LAB
X-LAB
87637311 5591637 Live/Registered
Thermogenesis Corp.
2017-10-06
X-LAB
X-LAB
87382662 not registered Live/Pending
Sagar Distribution LLC
2017-03-23

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