FDA.reportPublic FDA data

Moore Medical

Primary DI
20607415001192
Brand
Moore Medical
Company
MOORE MEDICAL LLC
Model
63347
Device description
Probe Cover Digital ThermBx100
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
40607415001202PackageGS150In Commercial Distribution
20607415001192PrimaryGS10
10607415003786Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4060741500120240607415001202
2060741500119220607415001192
1060741500378610607415003786

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
051420107
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607415001850Moore Medical932642016-12-09
10607415001874Moore Medical932672016-12-09
10607415001898Moore Medical932632016-12-09
10607415001911Moore Medical932662016-12-09
10607415001935Moore Medical932682016-12-09
10607415001959Moore Medical93269 2016-12-09
10607415001973Moore Medical932702016-12-09
10607415003656Moore Medical932652016-12-09
20607415000072Moore Medical827902016-12-09
20607415000096Moore Medical827912016-12-09
20607415000119Moore Medical827892016-12-09
10607415001614Moore Medical830302016-12-09
20607415001314Moore Medical137842016-12-09
20607415000010Moore Medical128422016-12-09
20607415000034Moore Medical128432016-12-09
20607415000058Moore Medical128442016-12-09
10607415001294Moore Medical137862016-12-09
10607415002055Moore Medical306442016-12-09
10607415002062Moore Medical306492016-12-09
10607415001997Moore Medical141702016-12-09

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Primary DI, Brand, Company table
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