FDA.reportPublic FDA data

Rectal Temperature Digital Thermometer

Primary DI
00612606001536
Brand
Rectal Temperature Digital Thermometer
Company
KERMA MEDICAL PRODUCTS, INC.
Model
16813
Catalog number
16813
Device description
Rectal Temperature Digital Thermometer
Published
2017-08-18
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
K940686000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940686000ELECTRONIC THERMOMETERSAmerican Diagnostic Corp.1994-07-08FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20612606001530PackageGS124In Commercial Distribution
00612606001536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061260600153020612606001530
00612606001536006126060015366126060015360612606001536

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.

Regulatory Flags#

DUNS number
787328772
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612606001512Oral Temperature Digital Thermometer16811168112017-08-18
00612606001529Oral Temperature Digital Thermometer16812168122017-08-18
00612606001543Rectal Digital Thermometer16816168162017-08-18
00612606001505Dual Scale Digital Thermometer16809168092017-08-18
20612606001516Oral Temperature Digital Thermometer16811168112017-08-18
20612606001523Oral Temperature Digital Thermometer16812168122017-08-18
20612606001530Rectal Temperature Digital Thermometer16813168132017-08-18
20612606001547Rectal Digital Thermometer16816168162017-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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