FDA.reportPublic FDA data

FDK

Primary DI
00859020006383
Brand
FDK
Company
Fudakang Industrial Inc.
Model
FT-F41A
Device description
FDK SPEAKING NON-CONTACT INFRARED THERMOMETER
Published
2022-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K111703000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111703000INFRARED EAR THEROMETERFudakang Industrial Co., Ltd.2012-03-29FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859020006380PackageGS16In Commercial Distribution
20859020006387PackageGS124In Commercial Distribution
00859020006383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085902000638010859020006380
2085902000638720859020006387
00859020006383008590200063838590200063830859020006383

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered 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
118811334
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859020006390FDKFT-E688 Plus2025-04-14
10859020006397FDKFT-E688 Plus2025-04-14
00859020006062FDKFT-F312016-12-01
00859020006154FDKFT-E6882021-11-24
00859020006192FDKFT-F332017-09-20
00859020006222FDKFT-C15Y2017-11-03
00859020006314FDKFT-C02-V (XL)2019-04-09
00859020006376FDKFT-C15BFT-C15B2023-12-31
00859020006420FDKFT-F412020-03-31
00859020006437FDKBT-A132020-05-13
00859020006475FDKFT-F342020-08-11
00859020006369FDKFT-C03-VFT-C03-V (L)2023-04-20
00859020006178FDKBT-A312019-12-10
00859020006000FDKFT-C22Y2016-12-21
00859020006017FDKBT-A11CN2016-12-21
00859020006024FDKBT-A21CN2016-12-21
00859020006031FDKBT-A41CN2016-12-21
00859020006048FDKFT-F112016-12-21
00859020006055FDKFT-F212016-12-21
00859020006079FDKFT-F322016-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22