Geratherm Daisy Color Pacifier Digital Thermometer 30070

GUDID 00614801300704

Daisy Infant Pacifier Thermometer is a clinical thermometer intended for the measurement of oral body temperature in infants and young children. The device is waterproof, uses a CR2032 (3 V) battery. Dimensions: 60 mm x 50 mm x 42 mm. Weight: Approx. 23 grams (including battery). Beeper: Approx. 5 secs. sound signal when end temperature reached. Memory: Built-in memory enabling display of the previously measured value. Shut-off: Automatic shut-off in approx. 30 seconds. Backlight Color Coded Visual fever alarm indicators green yellow and red : 36,0 T 37,1 green 37,2 T 37,4 yellow 37,5 T 43,9 red A protective storage cover included

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

Intermittent electronic patient thermometer
Primary Device ID00614801300704
NIH Device Record Key82701603-16e2-4dc4-af48-e3a0c510b09c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeratherm Daisy Color Pacifier Digital Thermometer
Version Model NumberRETAIL Baby Pacifier Thermometer
Catalog Number30070
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 Batchfalse
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
GS100614801300704 [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 Date2016-09-01

Devices Manufactured by R.G. ENTERPRISES (U.S.A.), INC.

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