Changke Connect

GUDID 16973874210176

Set of 20pcs products in a box

Shenzhen Changke Connect Electronics Co., Ltd.

Neurophysiologic monitoring system
Primary Device ID16973874210176
NIH Device Record Key957cacb9-0a8b-4e0a-9969-627e5e3b5677
Commercial Distribution StatusIn Commercial Distribution
Brand NameChangke Connect
Version Model NumberP01-001-00577
Company DUNS529906512
Company NameShenzhen Changke Connect Electronics Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS116973874210176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-20
Device Publish Date2022-05-12

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
16973874210138P01-001-00573
16973874210121P01-001-00572
16973874210114P01-001-00571
16973874210107P01-001-00570
06973874210261P01-001-00578
06973874210131P01-001-00565
06973874210124P01-001-00564
06973874210117P01-001-00563
06973874210100P01-001-00562
06973874210094GCF1205
06973874210087GCF1203
06973874210070GCF1204
06973874210063GCF1202
06973874210001GCF1200
16973874210176Set of 20pcs products in a box
16973874210169Set of 20pcs products in a box
16973874210152Set of 20pcs products in a box
16973874210145Set of 20pcs products in a box
06973874210179P01-001-00569
06973874210162P01-001-00568
06973874210155P01-001-00567
06973874210148P01-001-00566

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