Geratherm Colorchoice Rectal Digital Thermometer 30051

GUDID 00614801300513

The ColorChoice Rectal Digital non-flex tip thermometer is white with red accent colors around the display window and start button. The temperature measuring range is 90.0°F to 109.0°F. It uses a 1.55V battery with more than 200 hours of continuous use. An audible beep sounds with the peak temperature is reached and the Memory Mode displays the last reading. A battery replacement symbol will appear on the display when the battery is low with an auto shut off feature in 10 minutes. A clear protective case is provided.

R.G. ENTERPRISES (U.S.A.), INC.

Intermittent electronic patient thermometer
Primary Device ID00614801300513
NIH Device Record Key68838a3e-2ca3-4fcc-946b-3f6c48c67149
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeratherm Colorchoice Rectal Digital Thermometer
Version Model NumberRectal Digital Thermometer with red and white colo
Catalog Number30051
Company DUNS928998905
Company NameR.G. ENTERPRISES (U.S.A.), 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 Usetrue
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-Countertrue

Customer Support Contacts

Phone248-504-6726
EmailMaryRN@rgmd.com
Phone248-504-6726
EmailMaryRN@rgmd.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100614801300513 [Primary]
GS120614801300517 [Package]
Package: BAG [25 Units]
In Commercial Distribution

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 Date2016-09-01

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