FDA.reportPublic FDA data

FMT

Primary DI
08698870313751
Brand
FMT
Company
METKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETI
Model
E200-3060/SA
Device description
Reusable ECG - EKG Cables and Leadwires
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
08698870313751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08698870313751086988703137518698870313751

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
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
06946725572931APKAPK Technology Co.,Ltd.IKD2026-10-26
06946725502341APKAPK Technology Co.,Ltd.IKD2026-10-22
06946725500989APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500996APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501009APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501016APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501030APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501047APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501054APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501061APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501078APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501085APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501092APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501108APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501115APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501122APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501139APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501146APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501153APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501160APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501177APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501184APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501191APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501207APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501214APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501221APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501238APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501245APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501252APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501269APKAPK Technology Co.,Ltd.IKD2025-07-22