FDA.reportPublic FDA data

MED-LINK

Primary DI
06944414008242
Brand
MED-LINK
Company
Shenzhen Med-Link Electronics Tech Co.,Ltd.
Model
S0010NE-L
Published
2022-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120010000CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)Shenzhen Med-Link Electronics Tech Co., Ltd.2012-01-19DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944414008242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944414008242069444140082426944414008242

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527221129
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944414005289Med-linkVA008BBA2017-03-29
06944414010405Med-linkS0044D-S2017-03-30
06944414031462Med-linkS0044D-S2017-03-30
06944414037945Med-linkED023-3AI2017-03-30
06944414006910MED-LINKW0001BW0001B2022-12-20
06944414007108MED-LINKW0001G2022-12-19
06944414007115MED-LINKW0001FW0001F2022-12-20
06944414011747MED-LINKS0044D-S2022-12-20
06944414021227MED-LINKS0044D-S2022-12-20
06944414037778MED-LINKS0044D-S2022-12-20
06944414044639MED-LINKW0001C2022-12-21
06944414049962MED-LINKW0001C2022-12-20
06944414049979MED-LINKS0044D-S2022-12-20
06944414049986MED-LINKS0136J-L2022-12-20
06944414049993MED-LINKS0136J-L2022-12-20
06944414050005MED-LINKW0001B2022-12-20
06944414050029MED-LINKS0136J-L2022-12-20
06944414050050MED-LINKS0136J-L2022-12-21
06944414050067MED-LINKS0136J-L2022-12-21
06944414050074MED-LINKS0136J-L2022-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816396022553ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022560ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022577ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022706ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022713ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022812ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022829ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022836ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022843ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022850ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022911ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00840067102206Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-29
00840067102176Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00840067102183Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00009336008254VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2018-09-28
00840067102497Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2017-12-22
00816396022294ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2017-08-31
20884521148342KendallCardinal Health, Inc.DSA2017-08-02
00817266020778Patient Lead Wire Adapter SetMERIT CABLES INCORPORATEDDSA2017-05-09
00009336008216VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008223VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008230VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008247VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008261VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008278VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008315VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008322VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008339VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00841034110798ACQUISITION MODULE CABLERPIDSA2016-12-09
00841034110804ACQUISITION MODULE CABLERPIDSA2016-12-09