FDA.reportPublic FDA data

FMT

Primary DI
08698870368874
Brand
FMT
Company
METKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETI
Model
FMT400/AS/THT
Catalog number
FMT400/AS/THT
Device description
The reusable skin temperature probe is intended to measure and monitor body skin (surface) temperature and peripheral temperature changes, and to be used for continuous temperature monitoring during surgery, anesthesia, and intensive care.
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
FLLContinuous Measurement Thermometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213100000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213100000FMT Reusable Temperature ProbesMetko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti2023-07-18FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08698870368874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08698870368874086988703688748698870368874

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, reusableA temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a reusable device.

Regulatory Flags#

DUNS number
566222169
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08698870325211FMTFMT400/ASFMT400/AS2026-04-22
08698870325297FMTFMT400/AS-DFMT400/AS-D2026-04-22
08698870325310FMTFMT400/AOR-DFMT400/AOR-D2026-04-22
08698870325389FMTFMT400/AORFMT400/AOR2026-04-22
08698870335265FMTFMT400/PORFMT400/POR2026-04-22
08698870357830FMTFMT400/AOR-D2FMT400/AOR-D22026-04-22
08698870368867FMTFMT400/AS-D2FMT400/AS-D22026-04-22
08698870371577FMTFMT400/AS/MMMFMT400/AS/MMM2026-04-22
08698870372604FMTFMT400/AOR-D5FMT400/AOR-D52026-04-22
08698870376251FMTFMT400/AOR-D6FMT400/AOR-D62026-04-22
08698870377968FMTFMT400/AS-SFMT400/AS-S2026-04-22
08698870313720FMTE200-3060/GI2020-05-22
08698870313737FMTE200-3060/SI2020-05-22
08698870313744FMTE200-3060/GA2020-05-22
08698870313751FMTE200-3060/SA2020-05-22
08698870314765FMTE200-5060/GI2020-05-22
08698870314772FMTE200-5060/SI2020-05-22
08698870314789FMTE200-5060/GA2020-05-22
08698870314796FMTE200-5060/SA2020-05-22
08698870315816FMTE201-3060/GI2020-05-22

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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B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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