TWIN-PASS 5201

GUDID 30841156100364

Twin-Pass Torque

TELEFLEX INCORPORATED

Peripheral vascular infusion catheter

• Primary Device ID: 30841156100364
• NIH Device Record Key: c6bf4673-7af1-49a5-90cd-05ade6de1746
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TWIN-PASS
• Version Model Number: IPN913544
• Catalog Number: 5201
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM

Device Dimensions

• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841156100360 [Primary]
GS1	30841156100364 [Package]; Contains: 10841156100360; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162467

FDA Product Code

• DQY: Catheter, percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-09
• Device Publish Date: 2018-10-01

On-Brand Devices [TWIN-PASS]

• 30841156100364: Twin-Pass Torque
• 30841156100357: Twin-Pass V2, 3.5F
• 20841156107397: Twin-Pass V2
• 20841156109094: Twin-Pass Torque