FDA.reportPublic FDA data

GERATHERM MERCURY FREE GLASS HYPOTHYROID THERMOMETER

Primary DI
60614801400703
Brand
GERATHERM MERCURY FREE GLASS HYPOTHYROID THERMOMETER
Company
R.G. ENTERPRISES (U.S.A.), INC.
Model
GLASS HYPOTHYROID BASAL THERMOMETER WITH BLUE COL
Catalog number
40070
Device description
Hypothyroid Basal thermometer with magnifying case and blue retainer contains Galinstan, which is a non-toxic, liquid metal that replaces the toxic mercury. The expanded calibration strip provides an accurate temperature display with a magnifying (optical) case for easy temperature reading. It is suitable for oral or axillary temperature monitoring. Easy to clean or disinfect with alcohol or warm soapy water. Temperature measuring range is 97 degrees F to 101 degrees F.
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLKThermometer, Clinical Mercury

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLKThermometer, Clinical MercuryGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60614801400703PackageGS16In Commercial Distribution
00614801400701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6061480140070360614801400703
00614801400701006148014007016148014007010614801400701

GMDN Terms#

Term, Definition table
TermDefinition
Capillary patient thermometer, mercuryAn instrument designed to measure a patient's body temperature which is formed as a slender, hollow, sealed tube made of glass with a bulb at one end filled with mercury (Hg). It works on the capillary principle whereby the registered heat proportionally expands the medium, filling a graduated column. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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00614801001502Geratherm Medical Warming SystemsSuper Mini-Rescue II Unique Resc+ R-150806132016-08-31
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00614801000079Medical Warming SystemsAC/DC Adaptor Cable820142025-07-09
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00614801000000Medical Warming SystemsCharger Assembly Lithium Ion Battery820252025-04-03
00614801000017Medical Warming SystemsPower Supply Unit820092025-04-03
00614801000024Medical Warming SystemsBattery Adapter Cable820242025-04-03
00614801000031Medical Warming SystemsAux Vehicle Cable820192025-04-03
00614801000048Medical Warming SystemsUltralife Battery Assembly820392025-04-03
00614801000055Medical Warming SystemsBrentronics Battery Assembly820152025-04-03
00614801150118DataTherm IIDatatherm II5015012016-09-01
16148015015013DataTherm IIDatatherm II5015012016-09-01
00614801200103GERATHERM MERCURY FREE GLASS THERMOMETERORAL THERMOMETER200102016-09-01
00614801200417GERATHERM MAGNATHERM MERCURY CLINICAL FREE GLASS THERMOMETER GLASS ORAL THERMOMETER IN MAGNIFYING CASE200412016-09-01
00614801200516GERATHERM MERCURY FREE GLASS THERMOMETERRECTAL THERMOMETER200512016-09-01
00614801200615GerathermClinical Basal Thermometer200612016-09-01
00614801400701GERATHERM MERCURY FREE GLASS HYPOTHYROID THERMOMETER GLASS HYPOTHYROID BASAL THERMOMETER WITH BLUE COL400702016-09-01
20614801200107GERATHERM MERCURY FREE GLASS THERMOMETERORAL THERMOMETER200102016-09-01
00614801200301GERATHERM MERCURY FREE GLASS ORAL THERMOMETERRETAIL GLASS ORAL THERMOMETER200302016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00057475220495BIOS DiagnosticsThermor LtdFLK2023-09-20
10057475220492BIOS DiagnosticsThermor LtdFLK2023-09-20
04018674454681Geratherm® classic Geratherm Medical AGFLK2023-09-06
06972543480103Disposable Thermometer Cover and SheathsKANG ZE INDUSTRIAL CO., LTDFLK2019-08-23
06972543480110Disposable Thermometer Cover and SheathsKANG ZE INDUSTRIAL CO., LTDFLK2019-08-23
06972543480127Disposable Thermometer Cover and SheathsKANG ZE INDUSTRIAL CO., LTDFLK2019-08-23
00614801200103GERATHERM MERCURY FREE GLASS THERMOMETERR.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01
00614801200417GERATHERM MAGNATHERM MERCURY CLINICAL FREE GLASS THERMOMETERR.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01
00614801200516GERATHERM MERCURY FREE GLASS THERMOMETERR.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01
00614801200615GerathermR.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01
00614801400701GERATHERM MERCURY FREE GLASS HYPOTHYROID THERMOMETER R.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01
20614801200107GERATHERM MERCURY FREE GLASS THERMOMETERR.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01
00614801200301GERATHERM MERCURY FREE GLASS ORAL THERMOMETERR.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01
00614801200400GERATHERM MAGNATHERM MERCURY FREE GLASS THERMOMETERR.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01
20614801200411GERATHERM MAGNATHERM MERCURY CLINICAL FREE GLASS THERMOMETERR.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01
00614801200509GERATHERM MERCURY FREE GLASS THERMOMETERR.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01
20614801200510GERATHERM MERCURY FREE GLASS THERMOMETERR.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01
00614801200608GERATHERM MERCURY FREE BASAL GLASS THERMOMETERR.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01
20614801200619GerathermR.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01