SAFE-MATE

GUDID 00846127199377

CASE-MATE, INC.

Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin
Primary Device ID00846127199377
NIH Device Record Keyab4ff034-2fe9-4744-a617-fa99a459de14
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAFE-MATE
Version Model NumberLX-26E WHITE
Company DUNS790486612
Company NameCASE-MATE, INC.
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 Numbertrue
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
GS100846127199377 [Primary]
GS100846127199377 [Primary]
GS100846127199377 [Primary]
GS100846127199377 [Primary]
GS100846127199377 [Primary]
GS100846127199377 [Primary]
GS100846127199377 [Primary]
GS100846127199377 [Primary]
GS100846127199377 [Primary]
GS100846127199377 [Primary]
GS100846127199377 [Primary]
GS100846127199377 [Primary]
GS100846127199377 [Primary]
GS100846127199377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

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