GENTLECATH 1711836

GUDID 44026704582264

GentleCath Insertion Kit

TELEFLEX INCORPORATED

Single-administration urethral drainage catheter

• Primary Device ID: 44026704582264
• NIH Device Record Key: cf63c244-76fb-4440-8af8-77640e094f70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENTLECATH
• Version Model Number: IPN050232
• Catalog Number: 1711836
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	14026704582263 [Primary]
GS1	44026704582264 [Package]; Contains: 14026704582263; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010420

FDA Product Code

• FCM: Tray, catheterization, sterile urethral, with or without catheter (kit)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-10
• Device Publish Date: 2016-09-16

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• 20801902224297 - ARROW: 2025-12-10 Arrowg+ard Blue(R) PSI Kit for use with 7.5 - 8 Fr. Catheters
• 30801902192159 - ARROW: 2025-11-28 Arterial Catheterization Set
• 20801902193012 - ARROW: 2025-11-28 Emergency Infusion Device - EID(TM)
• 44026704617195 - TELEFLEX: 2025-11-28 TFX ISIS SUBGLOTTIC SEC. ETT, 7.0
• 44026704617201 - TELEFLEX: 2025-11-28 TFX ISIS SUBGLOTTIC SEC. ETT, 7.5
• 34026704617211 - TELEFLEX: 2025-11-28 TFX ISIS SUBGLOTTIC SEC. ETT, 8.0