Changke Connect

GUDID 06973874210001

Shenzhen Changke Connect Electronics Co., Ltd.

Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable
Primary Device ID06973874210001
NIH Device Record Key2f0a290f-d4c0-435e-92e1-0a492ba23593
Commercial Distribution StatusIn Commercial Distribution
Brand NameChangke Connect
Version Model NumberGCF1200
Company DUNS529906512
Company NameShenzhen Changke Connect Electronics Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973874210001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXQBlood Pressure Cuff

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06973874210001]

High-level Disinfectant


[06973874210001]

High-level Disinfectant


[06973874210001]

High-level Disinfectant


[06973874210001]

High-level Disinfectant


[06973874210001]

High-level Disinfectant


[06973874210001]

High-level Disinfectant


[06973874210001]

High-level Disinfectant


[06973874210001]

High-level Disinfectant


[06973874210001]

High-level Disinfectant


[06973874210001]

High-level Disinfectant


[06973874210001]

High-level Disinfectant


[06973874210001]

High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-14
Device Publish Date2022-03-04

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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