FDA.reportPublic FDA data

FMT

Primary DI
08698870337443
Brand
FMT
Company
METKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETI
Model
IBP-02/001
Device description
Reusable IBP (Invasive Blood Pressure) Adaptor and Extension Cable
Published
2020-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08698870337443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08698870337443086988703374438698870337443

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, blood pressure, invasiveA small unit dedicated to the measurement of invasive blood pressure (from one or more sites) obtained through a pressure transducer introduced directly into a blood vessel via a catheter. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
415 802-4021burcufirat@metkoltd.com

Regulatory Flags#

DUNS number
566222169
Device count
1
Premarket exempt
true
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
08698870368874FMTFMT400/AS/THTFMT400/AS/THT2026-04-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978035540010SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540027SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540034SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540041SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540058SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540065SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
00850087490122AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
00850087490146AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
06978035540003SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-05
00650551006602PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006619PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006626PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
04250307612871Adapter cable touchproof for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
04250307612888Connection cable for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
07613327688788N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-04-06
07613327643237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
07613327643244N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
03664539003559NADIXI MEDICALIKD2022-07-06
03664539003566NADIXI MEDICALIKD2022-07-06
03664539003573NADIXI MEDICALIKD2022-07-06
03664539003580NADIXI MEDICALIKD2022-07-06
03664539003603NADIXI MEDICALIKD2022-07-06
03664539003610NADIXI MEDICALIKD2022-07-06
03664539003627NADIXI MEDICALIKD2022-07-06
03664539003634NADIXI MEDICALIKD2022-07-06
08033695721525NAFIAB SPAIKD2021-07-08
08033695726278NAFIAB SPAIKD2020-06-13
08033695726995NAFIAB SPAIKD2020-06-13
08054242441734NAFIAB SPAIKD2020-06-13
08054953345864NAFIAB SPAIKD2020-06-13