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 ID: 16950900965323
• NIH Device Record Key: 51143fa8-68e9-43eb-a9df-f342d5df2561
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INT
• Version Model Number: YCK100F
• Company DUNS: 420827639
• Company Name: Shanghai Kindly Medical Instruments Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06950900965326 [Primary]
GS1	16950900965323 [Package]; Contains: 06950900965326; Package: box [25 Units]; In Commercial Distribution
GS1	26950900965320 [Package]; Contains: 06950900965326; Package: box [50 Units]; In Commercial Distribution
GS1	46950900965324 [Package]; Contains: 06950900965326; Package: carton [200 Units]; In Commercial Distribution
GS1	56950900965321 [Package]; Contains: 06950900965326; Package: carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170024

FDA Product Code

• DTL: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-22
• Device Publish Date: 2023-08-14

On-Brand Devices [INT]

• 26950900961582: CHTR04
• 26950900942901: 90cm*1200psi, 1.8*3.6mm, PU+PA, male/female luer lock, with cap
• 26950900942895: 60 cm*1200 psi, 1.8*3.6 mm, PU+PA, male/female luer lock, with cap
• 26950900942888: PMT0301
• 26950900926789: 120cm*1200psi, 1.8*3.6mm, PU+PA, male/female luer lock, with cap
• 26950900926390: CHTR04A
• 26950900926376: CHTR03A
• 26950900926352: HTR04A
• 26950900926338: HTR03A
• 26950900926314: CTR04A
• 26950900926291: CTR03A
• 26950900923733: HTR04
• 26950900923719: HTR03
• 26950900923696: CHTR03
• 26950900923542: CTR03
• 26950900923061: CTR04
• 26950900921142: TR04A
• 26950900921135: TR04
• 26950900921128: TR03A
• 26950900921111: TR03
• 26950900920657: 150cm*1200psi, 1.8*3.6mm, PU+PA, rotating male/female luer lock, with cap
• 26950900920640: 90 cm*1200 psi, 1.8*3.6 mm, PU+PA, rotating male/female luer lock, with cap
• 26950900920633: 60cm*1200psi, 1.8*3.6mm, PU+PA, rotating male/female luer lock, with cap
• 26950900920626: PMT0501
• 26950900920565: IS01
• 26950900920374: 6ml, fixed adapter
• 26950900920367: 6ml, rotating adapter
• 26950900920350: 8ml, fixed adapter
• 26950900920336: PMT0504
• 26950900920312: IS04
• 26950900920305: IS03
• 06950900920295: IS02
• 26950900920251: 8ml, rotating adapter
• 26950900920244: 10ml, fixed adapter
• 26950900920237: 10ml, rotating adapter
• 26950900920220: 12ml, fixed adapter
• 26950900920213: 12ml, rotating adapter
• 16950900965323: Push-Rotate Y connector with 15 cm extension tube,45 psi stopcock, torque device, insertion tool
• 16950900965316: Push-Rotate type Y connector
• 16950900965309: Push-Rotate Y connector, torque device, insertion tool
• 16950900941396: Push-click type Y connector
• 16950900929400: Screw type Y connector,torque device(copper core), insertion tool
• 26950900923405: Push-pull Y connector with 15 cm extension tube,45 psi stopcock, torque device, insertion tool
• 16950900922357: Push-click Y connector, torque device, insertion tool
• 16950900922296: Push-pull Y connector, torque device, insertion tool
• 16950900922227: Screw type Y connector
• 26950900922217: Push-click Y connector with 15 cm extension tube, torque device, insertion tool
• 16950900922067: Push-pull type Y connector
• 26950900921852: Screw type Y connector with 15 cm extension tube, 45 psi stopcock,torque device, insertion tool
• 16950900921701: Screw type Y connector,torque device(plastic core), insertion tool