FDA.reportPublic FDA data

BIOS Diagnostics

Primary DI
00057475220495
Brand
BIOS Diagnostics
Company
Thermor Ltd
Model
220DI
Device description
Glass Thermometer
Published
2023-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10057475220492PackageGS16Not in Commercial Distribution
80057475220491PackageGS14Not in Commercial Distribution
00057475220495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747522049210057475220492
8005747522049180057475220491
00057475220495000574752204950574752204950057475220495

GMDN Terms#

Term, Definition table
TermDefinition
Capillary patient thermometer, gallium-alloyAn 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 a non-toxic liquid gallium alloy (typically alloyed with indium and tin). It works on the capillary principle whereby the registered heat proportionally expands the medium, filling a graduated column. This is a reusable device.

Regulatory Flags#

DUNS number
246883458
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00057475032500BIOS DiagnosticsW2502026-01-19
00057475491505BIOS DiagnosticsNS1502026-01-19
20057475032504BIOS DiagnosticsW2502026-01-19
00057475242909BIOS DiagnosticsBD2902026-01-19
10057475491502BIOS DiagnosticsNS1502026-01-19
00057475820213BIOS LivingRL0212026-01-19
00057475282493BIOS282DI2023-05-23
00057475282738BIOS LivingLH2732024-03-21
00057475282745BIOS LivingLH2742024-03-21
00057475561017BIOS LivingEP1012024-03-22
00057475561024BIOS LivingEP1022024-03-22
00057475561031BIOS LivingEP1032024-03-23
00057475561048BIOS LivingEP1042024-03-23
00057475561055BIOS LivingEP1052024-03-22
00057475561062BIOS LivingEP1062024-03-22
00057475561079BIOS LivingEP1072024-03-22
00057475561086BIOS LivingEP1082024-03-22
00057475561093BIOS LivingEP1092024-03-22
00057475561222BIOS LivingEP1222024-03-22
00057475561239BIOS LivingEP1232024-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
60614801400703GERATHERM MERCURY FREE GLASS HYPOTHYROID THERMOMETER R.G. ENTERPRISES (U.S.A.), INC.FLK2016-09-01