PXP-1000

GUDID 00886368000087

PXP-1000 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
Primary Device ID00886368000087
NIH Device Record Key73a556d1-2d38-4b50-9fb3-ade745f2d7cc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePXP-1000
Version Model Number80102
Company DUNS080690327
Company NameThermogenesis Corp.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
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 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
GS100886368000087 [Unit of Use]
GS100886368000117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAOCord Blood Processing System And Storage Container

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

Radiation Sterilization


[00886368000087]

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 [PXP-1000]

00886368000124PXP-1000 Disposable Cartridge
00886368000087PXP-1000 Disposable Cartridge
00886368000100PXP-1000 Disposable Cartridge
00886368000056PXP-1000 Control Module

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