FDA.reportPublic FDA data

Oral Temperature Digital Thermometer

Primary DI
20612606001523
Brand
Oral Temperature Digital Thermometer
Company
KERMA MEDICAL PRODUCTS, INC.
Model
16812
Catalog number
16812
Device description
Dual Scale Oral Digital Thermometer with 20 Probe Covers, 60 second read
Published
2017-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
20612606001523PackageGS124In Commercial Distribution
00612606001529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061260600152320612606001523
00612606001529006126060015296126060015290612606001529

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

Regulatory Flags#

DUNS number
787328772
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612606001512Oral Temperature Digital Thermometer16811168112017-08-18
00612606001529Oral Temperature Digital Thermometer16812168122017-08-18
00612606001536Rectal Temperature Digital Thermometer16813168132017-08-18
00612606001543Rectal Digital Thermometer16816168162017-08-18
00612606001505Dual Scale Digital Thermometer16809168092017-08-18
20612606001516Oral Temperature Digital Thermometer16811168112017-08-18
20612606001530Rectal Temperature Digital Thermometer16813168132017-08-18
20612606001547Rectal Digital Thermometer16816168162017-08-18

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Primary DI, Brand, Company table
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06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22