Geratherm SolarTherm Speed Digital Thermometer

Primary DI
00614801400534
Brand
Geratherm SolarTherm Speed Digital Thermometer
Company
R.G. ENTERPRISES (U.S.A.), INC.
Model
Retail SolarTherm Digital Thermomete
Catalog number
40053
Device description
SolarTherm Speed digital flex tip thermometer is white with blue accent colors and is used to measure body temperatures orally, rectally or axillary. The temperature measuring range is from 89.6°~111.0°F. If the reading is below 89.6°F, the letter L will be displayed indicating Low reading. If the reading is above 111.0°F, the letter H will be displayed indicating High reading. Energy is supplied using an integrated solar cell with approximately 25 temperature readings within 60-minutes before a recharge is needed. There is an audible beeping for 8 seconds after peak temperature is reached, built-in memory recall enabling display of the previously measured and automatic shut-off in about 9 minutes. Prior to using the solar cell must be exposed to a light source at least 3 hours. This may be in room light or sunlight. A half circle symbol will appear in the display when the solar cell needs to be recharged. Turn the power off before recharging, the solar cell should face the light source during recharging and for ongoing use store on counter top where thermometer is exposed to light throughout the day. A clear plastic cover is provided.
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903590000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903590000KEJUMP DIGITAL CLINICAL THERMOMETERK-Jump Health Co., Ltd.1990-10-22FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614801400534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614801400534006148014005346148014005340614801400534

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent electronic patient thermometerA hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
248-504-6726MaryRN@rgmd.com

Regulatory Flags#

DUNS number
928998905
Device count
1
Lot or batch
true

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