PXP-1000

GUDID 00886368000056

PXP-1000 Control Module

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 ID00886368000056
NIH Device Record Keyd1479485-c966-4e64-a466-a0e3f28520b8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePXP-1000
Version Model Number80104
Company DUNS080690327
Company NameThermogenesis Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

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
GS100886368000049 [Direct Marking]
GS100886368000056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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

On-Brand Devices [PXP-1000]

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

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