FDA.reportPublic FDA data

Up & Up

Primary DI
20810125112885
Brand
Up & Up
Company
TARGET CORPORATION
Model
DT002
Published
2024-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical
SDVClinical Electronic Thermometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2
SDVClinical Electronic ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163603000Digital ThermometerGuangzhou Jinxinbao Electronic Co., Ltd.2017-06-06FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810125112885PackageGS112In Commercial Distribution
00810125112881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081012511288520810125112885
00810125112881008101251128818101251128810810125112881

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
006961700
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Model table
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00017276226218Up&Up2450704082020-02-28
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00017276231625Up&Up2450706522020-03-30
00017276233094Up&Up2450705762020-02-28
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Primary DI, Brand, Company table
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06970289035946hetaidaHetaida Technology Co., LtdSDV2026-10-16
06970289035953hetaidaHetaida Technology Co., LtdSDV2026-10-16
06970289035960hetaidaHetaida Technology Co., LtdSDV2026-10-16
06970289035977hetaidaHetaida Technology Co., LtdSDV2026-10-16
00850078377388iHealthiHealth Labs Inc.SDV2026-10-12
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyFLL2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyFLL2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
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00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00845717012188TrackstarVERIDIAN HEALTHCARE LLCSDV2026-09-04
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06944413835214Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
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06933257923157YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
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06933257952751YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
06942284618080JOYTECHJOYTECH HEALTHCARE CO.,LTDSDV2026-08-14
00885403523437HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
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06970289030859foreverlittleHetaida Technology Co., LtdFLL2026-07-28
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