3D Bag Set

GUDID 00886368000148

3D Bag Set

Thermogenesis Corp.

Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container
Primary Device ID00886368000148
NIH Device Record Key536a33bc-0029-4243-96c4-5103ed9dc618
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D Bag Set
Version Model Number80105
Company DUNS080690327
Company NameThermogenesis Corp.
Device Count20
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100886368000131 [Unit of Use]
GS100886368000148 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


[00886368000148]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-12
Device Publish Date2021-10-04

Devices Manufactured by Thermogenesis Corp.

00886368000605 - PXP2021-10-15 PXP Disposable Cartridge
00886368000148 - 3D Bag Set2021-10-123D Bag Set
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
00886368000865 - X-Counterweight2021-10-12 X-Counterweight Low Packaged
00886368000889 - X-Counterweight2021-10-12 X-Counterweight Medium Packaged
00886368000902 - X-Counterweight2021-10-12 X-Counterweight High Packaged

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