INT

GUDID 16950900965323

Push-Rotate Y connector with 15 cm extension tube,45 psi stopcock, torque device, insertion tool;

Shanghai Kindly Medical Instruments Co., Ltd.

Vascular guidewire introduction sleeve
Primary Device ID16950900965323
NIH Device Record Key51143fa8-68e9-43eb-a9df-f342d5df2561
Commercial Distribution StatusIn Commercial Distribution
Brand NameINT
Version Model NumberYCK100F
Company DUNS420827639
Company NameShanghai Kindly Medical Instruments 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 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
GS106950900965326 [Primary]
GS116950900965323 [Package]
Contains: 06950900965326
Package: box [25 Units]
In Commercial Distribution
GS126950900965320 [Package]
Contains: 06950900965326
Package: box [50 Units]
In Commercial Distribution
GS146950900965324 [Package]
Contains: 06950900965326
Package: carton [200 Units]
In Commercial Distribution
GS156950900965321 [Package]
Contains: 06950900965326
Package: carton [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-22
Device Publish Date2023-08-14

On-Brand Devices [INT]

26950900961582CHTR04
2695090094290190cm*1200psi, 1.8*3.6mm, PU+PA, male/female luer lock, with cap;
2695090094289560 cm*1200 psi, 1.8*3.6 mm, PU+PA, male/female luer lock, with cap;
26950900942888PMT0301
26950900926789120cm*1200psi, 1.8*3.6mm, PU+PA, male/female luer lock, with cap;
26950900926390CHTR04A
26950900926376CHTR03A
26950900926352HTR04A
26950900926338HTR03A
26950900926314CTR04A
26950900926291CTR03A
26950900923733HTR04
26950900923719HTR03
26950900923696CHTR03
26950900923542CTR03
26950900923061CTR04
26950900921142TR04A
26950900921135TR04
26950900921128TR03A
26950900921111TR03
26950900920657150cm*1200psi, 1.8*3.6mm, PU+PA, rotating male/female luer lock, with cap;
2695090092064090 cm*1200 psi, 1.8*3.6 mm, PU+PA, rotating male/female luer lock, with cap
2695090092063360cm*1200psi, 1.8*3.6mm, PU+PA, rotating male/female luer lock, with cap;
26950900920626PMT0501
26950900920565IS01
269509009203746ml, fixed adapter;
269509009203676ml, rotating adapter;
269509009203508ml, fixed adapter;
26950900920336PMT0504
26950900920312IS04
26950900920305IS03
06950900920295IS02
269509009202518ml, rotating adapter;
2695090092024410ml, fixed adapter;
2695090092023710ml, rotating adapter;
2695090092022012ml, fixed adapter;
2695090092021312ml, rotating adapter;
16950900965323Push-Rotate Y connector with 15 cm extension tube,45 psi stopcock, torque device, insertion tool
16950900965316Push-Rotate type Y connector;
16950900965309Push-Rotate Y connector, torque device, insertion tool;
16950900941396Push-click type Y connector;
16950900929400Screw type Y connector,torque device(copper core), insertion tool;
26950900923405Push-pull Y connector with 15 cm extension tube,45 psi stopcock, torque device, insertion tool;
16950900922357Push-click Y connector, torque device, insertion tool;
16950900922296Push-pull Y connector, torque device, insertion tool;
16950900922227Screw type Y connector
26950900922217Push-click Y connector with 15 cm extension tube, torque device, insertion tool;
16950900922067Push-pull type Y connector;
26950900921852Screw type Y connector with 15 cm extension tube, 45 psi stopcock,torque device, insertion tool;
16950900921701Screw type Y connector,torque device(plastic core), insertion tool;

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