FDA.reportPublic FDA data

UP&UP

Primary DI
00845717010016
Brand
UP&UP
Company
TARGET CORPORATION
Model
094-06-0014
Catalog number
48-343
Device description
UP&UP Ear/Forehead Digital Infrared Digital Thermometer
Published
2020-11-24
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
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100488000IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081Shenzhen Dongdixin Technology Co., Ltd.2010-07-22FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845717010013PackageGS124In Commercial Distribution
30845717010017PackageGS13In Commercial Distribution
00845717010016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084571701001310845717010013
3084571701001730845717010017
00845717010016008457170100168457170100160845717010016

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, battery-powered, electronic instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006961700
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00017276229370Up&Up2450706862020-01-24
00095072096006Up&Up 245-09-78819SMPP1002TG2026-04-22
00017276226171Up&Up2450701462020-02-28
00017276226188Up&Up2450702042020-02-28
00017276226218Up&Up2450704082020-02-28
00017276226270Up&Up2450710342020-02-28
00017276229363Up&Up2450706792020-01-24
00017276231625Up&Up2450706522020-03-30
00017276233094Up&Up2450705762020-02-28
00017276238655Up&Up2450778132022-02-14
00017276239614up&up2450749432024-02-05
00751774733532Up & Up Advanced Early Result Pregnancy Test2020-09-21
00751774733631Up & Up Advanced Early Result Pregnancy Test2020-09-28
06941937216819Up & Up245-07-02932022-07-12
00310119304242up & up multipurpose solution630424FCP-41222026-01-09
06945397906228Up&Up245-07-07092024-03-01
06945397906242Up&Up245-07-05902024-03-01
06945397906266Up&Up245-07-05952024-03-01
06945397906204Up&Up245-07-07072024-03-01
06945397902442Up&Up245-07-01042021-01-07

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Primary DI, Brand, Company table
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
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06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22