Changke Connect

GUDID 06973874210025

Shenzhen Changke Connect Electronics Co., Ltd.

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable
Primary Device ID06973874210025
NIH Device Record Key83b26b61-a141-48df-a804-11153c0c5bc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameChangke Connect
Version Model NumberCK-SMD-582A1-03AR2
Company DUNS529906512
Company NameShenzhen Changke Connect Electronics Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973874210025 [Primary]
GS106973874210025 [Primary]
GS106973874210025 [Primary]
GS106973874210025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSACable, Transducer And Electrode, Patient, (Including Connector)
DSACable, Transducer And Electrode, Patient, (Including Connector)
DSACable, Transducer And Electrode, Patient, (Including Connector)
DSACable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

On-Brand Devices [Changke Connect]

06973874210056CK-SMD-982A1-05AR2
06973874210049CK-SMD-582A1-05AR2
06973874210032CK-SMD-A82A1-03AN2
06973874210025CK-SMD-582A1-03AR2
06973874210018CK-SMD-481A1-12AR2

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