Performer HT R5100071

GUDID M640R51000710001

RAND SPA

Intravascular/intracavitary-circulation hyperthermia system
Primary Device IDM640R51000710001
NIH Device Record Key2a2d0566-91fc-4950-9fed-d4699fa3166a
Commercial Distribution Discontinuation2018-09-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePerformer HT
Version Model Number000
Catalog NumberR5100071
Company DUNS655010531
Company NameRAND SPA
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM640R51000710001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGZWarmer, Thermal, Infusion Fluid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-04-17
Device Publish Date2017-01-25

On-Brand Devices [Performer HT]

M640R51000710031003
M640R51000710001000
M640R51000710041004

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