FDA.reportPublic FDA data

Thermometer

Primary DI
00786511085032
Brand
Thermometer
Company
RASHMAN CORPORATION
Model
DT-6-WHT
Device description
Digital Thermometer-WHT-CB
Published
2018-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K981337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981337000DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834AMesure Technology1998-09-30FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00786511085032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00786511085032007865110850327865110850320786511085032

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, battery-powered, electronic instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078803608
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00786511077938StethoscopeS121-AQS2022-12-06
00786511249236StethoscopeS120-BLK2022-12-06
00786511249243StethoscopeS120-ROY2022-12-06
00786511249250StethoscopeS120-PUR2022-12-06
00786511249267StethoscopeS120-SAS2022-12-06
00786511462192StethoscopeS108-HPK2022-12-06
00786511559113StethoscopeS108-STE2022-12-06
00786511563851StethoscopeS121-BLK2022-12-06
00786511566463StethoscopeS108-P-HPK2022-12-06
00786511566470StethoscopeS108-I-HPK2022-12-06
00786511566913StethoscopeS108-CBL2022-12-06
00786511624958StethoscopeS108-P-BLK2022-12-06
00786511629106StethoscopeS108-I-BLK2022-12-06
00786511629113StethoscopeS108-BLK2022-12-06
00786511629274StethoscopeS106-BLK2022-12-06
00786511769116StethoscopeS108-NAV2022-12-06
00786511869113StethoscopeS108-ROY2022-12-06
00786511879112StethoscopeS108-TEA2022-12-06
00786511939113StethoscopeS108-PUR2022-12-06
00786511077839StethoscopeS126-AQS2022-12-05

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