T-Port

GUDID 07640110982112

T-Port HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs

PFM MEDICAL INCORPORATED

Vascular port/catheter

• Primary Device ID: 07640110982112
• NIH Device Record Key: 6017ad8c-9ae5-430a-9bef-55b1da1d179b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-Port
• Version Model Number: 616.365.2088-HA
• Company DUNS: 097736867
• Company Name: PFM MEDICAL 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: 7607588749
• Email: regulatory@pfmmedicalusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640110982112 [Package]; Contains: 07640110988374; Package: Box [20 Units]; In Commercial Distribution
GS1	07640110988374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073210

FDA Product Code

• LJT: Port & Catheter, Implanted, Subcutaneous, Intravascular

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: 2020-03-06
• Device Publish Date: 2020-02-27

On-Brand Devices [T-Port ]

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• 76401109884110: T-PORT LP HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
• 76401109883984: T-PORT LP HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter
• 76401109883748: T-PORT HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
• 76401109883502: T-PORT HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter
• 76401109883366: T-PORT HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
• 76401109875378: T-Port PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
• 76401109874760: T-Port LP PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
• 76401109872544: T-Port Silicone Kit HF with 8.4F x 750 mm Attachable Silicone Catheter
• 76401109872476: T-Port PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
• 76401109854960: T-PORT LP HP PUR Kit with 8F x 750 mm Pre-attached Polyurethane Catheter and Silicone Plugs
• 07640110982136: T-Port LP HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
• 07640110980842: T-Port LP HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter
• 07640110982150: T-Port LP HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
• 07640110982143: T-Port LP HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter
• 07640110982112: T-Port HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
• 07640110982105: T-Port HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter
• 07640110982129: T-Port HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
• 07640110981603: T-Port PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
• 07640110981696: T-Port LP PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
• 07640110981795: T-Port Silicone Kit HF with 8.4F x 750 mm Attachable Silicone Catheter
• 07640110981597: T-Port PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
• 07640110981924: T-Port LP HP PUR Kit with 8F x 750 mm Pre-attached Polyurethane Catheter and Silicone Plugs
• 00813623010789: 8F T-Port LP HP PUR Kit
• 00813623010499: 8F T-Port LP HP PUR Kit (filled)
• 00813623010482: 8F T-Port LP HP PUR Kit (non-filled)
• 00813623010475: 6.6F T-Port LP HP PUR Kit (filled)
• 00813623010468: 6.6F T-Port LP HP PUR Kit (non-filled)
• 00813623010451: 8F T-Port HP PUR Kit (filled)
• 00813623010444: 8F T-Port HP PUR Kit (non-filled)
• 00813623010437: 6.6F T-Port HP PUR Kit