FDA.reportPublic FDA data

Changke Connect

Primary DI
06973874210131
Brand
Changke Connect
Company
Shenzhen Changke Connect Electronics Co., Ltd.
Model
P01-001-00565
Published
2022-03-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
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
K200026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200026000Disposable ECG CableShenzhen Changke Connect Electronics Co., Ltd.2020-05-12DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973874210131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973874210131069738742101316973874210131

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, single-useA collection of non-sterile, noninvasive devices intended to be used 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 includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529906512
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973874210100Changke ConnectP01-001-005622022-03-04
06973874210117Changke ConnectP01-001-005632022-03-04
06973874210124Changke ConnectP01-001-005642022-03-04
06973874210261Changke ConnectP01-001-005782022-03-04
16973874210107Changke ConnectP01-001-005702022-03-04
16973874210114Changke ConnectP01-001-005712022-03-04
16973874210121Changke ConnectP01-001-005722022-03-04
16973874210138Changke ConnectP01-001-005732022-03-04
06973874210018Changke ConnectCK-SMD-481A1-12AR22020-11-02
06973874210025Changke ConnectCK-SMD-582A1-03AR22020-11-02
06973874210032Changke ConnectCK-SMD-A82A1-03AN22020-11-02
06973874210049Changke ConnectCK-SMD-582A1-05AR22020-11-02
06973874210056Changke ConnectCK-SMD-982A1-05AR22020-11-02
06973874210148Changke ConnectP01-001-005662022-05-12
06973874210155Changke ConnectP01-001-005672022-05-12
06973874210162Changke ConnectP01-001-005682022-05-12
06973874210179Changke ConnectP01-001-005692022-05-12
16973874210145Changke ConnectP01-001-005742022-05-12
16973874210152Changke ConnectP01-001-005752022-05-12
16973874210169Changke ConnectP01-001-005762022-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840416606898FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606904FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606911FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606928FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606935FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606942FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606959FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
08719689142209QMAPP Fysicon B.V.DSA2026-05-19
08719689142216QMAPP Fysicon B.V.DSA2026-05-19
08719689142223QMAPP Fysicon B.V.DSA2026-05-19
08719689142247QMAPP Fysicon B.V.DSA2026-05-19
08719689142254QMAPP Fysicon B.V.DSA2026-05-19
08719689142261QMAPP Fysicon B.V.DSA2026-05-19
08719689142322QMAPPFysicon B.V.DSA2026-05-19
08719689142339QMAPPFysicon B.V.DSA2026-05-19
08719689142346QMAPPFysicon B.V.DSA2026-05-19
08719689142353QMAPPFysicon B.V.DSA2026-05-19
08719689142360QMAPPFysicon B.V.DSA2026-05-19
08719689142377QMAPPFysicon B.V.DSA2026-05-19
08719689142384QMAPPFysicon B.V.DSA2026-05-19
08719689142391QMAPPFysicon B.V.DSA2026-05-19
08719689142407QMAPPFysicon B.V.DSA2026-05-19
08719689142414QMAPPFysicon B.V.DSA2026-05-19
08719689142469QMAPPFysicon B.V.DSA2026-05-19
08719689142476QMAPPFysicon B.V.DSA2026-05-19
08719689142483QMAPPFysicon B.V.DSA2026-05-19
08719689142490QMAPPFysicon B.V.DSA2026-05-19
08719689142506QMAPPFysicon B.V.DSA2026-05-19
08719689142513QMAPPFysicon B.V.DSA2026-05-19
08719689142520QMAPPFysicon B.V.DSA2026-05-19