Sovereign-Gear

GUDID 05060505400014

A home-use infrared forehead thermometer.

COOL APPROACH LIMITED

Intermittent electronic patient thermometer
Primary Device ID05060505400014
NIH Device Record Keybbfa4284-4ae1-4691-9918-d2e980b453e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSovereign-Gear
Version Model NumberFT-100D
Company DUNS672138455
Company NameCOOL APPROACH 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 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
GS105060505400014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

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 Date2016-10-21

On-Brand Devices [Sovereign-Gear]

05060505400014A home-use infrared forehead thermometer.
05060505400007A flexible tipped home-use waterproof digital thermometer.

Trademark Results [Sovereign-Gear]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOVEREIGN-GEAR
SOVEREIGN-GEAR
88041295 not registered Live/Pending
Attwood, Mark D
2018-07-17
SOVEREIGN-GEAR
SOVEREIGN-GEAR
88041295 not registered Live/Pending
Attwood, Caroline M
2018-07-17
SOVEREIGN-GEAR
SOVEREIGN-GEAR
88041295 not registered Live/Pending
Cool Approach Limited
2018-07-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.