PSCS Coolant

GUDID B5613LCOOLANT0

PAXMAN COOLERS LIMITED

Scalp cooling system
Primary Device IDB5613LCOOLANT0
NIH Device Record Key64acc73d-65c6-4f7b-ba83-3fbdaf86bf7a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePSCS Coolant
Version Model Number3L
Company DUNS519917264
Company NamePAXMAN COOLERS LIMITED
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB5613LCOOLANT0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMCScalp Cooling System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-05

On-Brand Devices [PSCS Coolant]

B561COOLANTCOMMPACK1Comm Pack
B5613LCOOLANT03L
B5611LCOOLANT01L
B561COOLANTBATCH1Coolant Batch

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