CytoTherm

GUDID 00861128000323

Plasma Thawing System

CYTOTHERM LP

Plasma thawing unit
Primary Device ID00861128000323
NIH Device Record Keyd6a69388-afeb-4644-bd43-a7a97ac96b08
Commercial Distribution StatusIn Commercial Distribution
Brand NameCytoTherm
Version Model NumberCT-4T.6C
Company DUNS057143901
Company NameCYTOTHERM LP
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 Datefalse
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
GS100861128000323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KZLDevice, Warming. Blood And Plasma

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

On-Brand Devices [CytoTherm]

00861128000354Plasma Thawing System
00861128000347Plasma Thawing System
00861128000330Plasma Thawing System
00861128000323Plasma Thawing System
00861128000316Plasma Thawing System
00861128000309Plasma Thawing System

Trademark Results [CytoTherm]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CYTOTHERM
CYTOTHERM
78427328 2985360 Live/Registered
Kuzyk, Roman
2004-05-28

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