TempTouch

GUDID G518TTIM112300150000101

Infrared patient thermometer, skin

Primary Device ID	G518TTIM112300150000101
NIH Device Record Key	9ab013fd-8c86-4fbf-b530-29d8e8c15749
Commercial Distribution Status	In Commercial Distribution
Brand Name	TempTouch
Version Model Number	IM1
Company DUNS	079944942
Company Name	Mr3 Health, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	G518TTIM112300150000101 [Primary]

FLL	Thermometer, Electronic, Clinical

Steralize Prior To Use	false
Device Is Sterile	false

Mark Image Registration \| Serial	Company Trademark Application Date
TEMPTOUCH 87487250 5375210 Live/Registered	MR3 Health, Inc. 2017-06-13
TEMPTOUCH 87313016 not registered Live/Pending	Serta, Inc. 2017-01-25
TEMPTOUCH 78259011 2986221 Dead/Cancelled	Xilas Medical, Inc. 2003-06-05