TOPCARE

Primary DI
00036800396920
Brand
TOPCARE
Company
Topco Associates, LLC
Model
87-639-000
Catalog number
87-639-000
Device description
60 SECOND DIGITAL THERMOMETER
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OZKThermometer, Exhaled Breath

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZKThermometer, Exhaled BreathGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962520000DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823AMesure Technology1996-09-12FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10036800396927PackageGS172In Commercial Distribution
00036800396920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003680039692710036800396927
00036800396920000368003969200368003969200036800396920

GMDN Terms#

Term, Definition table
TermDefinition
Continuous electronic patient thermometer, battery-poweredA battery-powered, electronic instrument designed to continuously measure (monitor) a patient's body temperature (e.g., during the administration of general anaesthesia, treatment of hypothermia and hyperthermia). It comprises an electronic unit and an attached probe that detects and converts the changes in temperature into variations of an electric characteristic, e.g., resistance or voltage. These variations of the electric characteristic are processed in the electronic circuits and continuously displayed as temperature readings. This is a reusable device.

Regulatory Flags#

DUNS number
072943876
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00036800216587TopCare health0368002165872019-07-31
00036800216600TopCare health0368002166002019-07-31
00036800413634TopCare health0368004136342019-10-31
00036800024892TopCare health0368000248922026-02-05
10036800024899TopCare health0368000248922026-02-05
00036800024908TopCare health0368000249082026-01-30
10036800024905TopCare health0368000249082026-01-30
00036800022683TopCare HealthTOP4045V2TOP4045V22026-01-27
80368000226834TopCare HealthTOP4045V2TOP4045V22026-01-27
20036800367436TopCare Premium Blood Glucose Meter8000-071642016-09-24
00036800250789TopCare Insulin Syringe1029122016-10-04
00036800250826TopCare Insulin Syringe0331082016-09-24
20036800367443TopCare Premium Blood Glucose Test Strips8000-071582016-09-24
20036800422159TopCare Premium Blood Glucose Test Strips8000-104432016-09-24
00036800250796TopCare Insulin Syringe0330082016-09-24
00036800250802TopCare Insulin Syringe0530082016-09-24
00036800250833TopCare Insulin Syringe0531082016-09-24
00036800250840TopCare Insulin Syringe1031082016-09-24
00036800250765TopCare Insulin Syringe0329122016-09-24
00036800250772TopCare Insulin Syringe0529122016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063675130LPOWHangzhou Universal Electronic Co.,Ltd.OZK2024-05-28
00767056156395MABISD-M-S HOLDINGS, INC.OZK2016-09-23
00767056156814MABISD-M-S HOLDINGS, INC.OZK2016-09-23
10767056156392MABISD-M-S HOLDINGS, INC.OZK2016-09-23
10767056156811MABISD-M-S HOLDINGS, INC.OZK2016-09-23
10036800396927TOPCARETopco Associates, LLCOZK2016-09-12
00681131060271RELIONWAL-MART STORES, INC.OZK2016-08-17
10681131060278RELIONWAL-MART STORES, INC.OZK2016-08-17