Jet Port Plus II

GUDID 07640110981931

Jet Port Plus II HP PUR Kit with 8F x 750 mm Pre-attached Polyurethane Catheter and Silicone Plugs

PFM MEDICAL INCORPORATED

Vascular port/catheter

• Primary Device ID: 07640110981931
• NIH Device Record Key: 1a4e48f6-7f09-41cf-8b52-d3026e9dad31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jet Port Plus II
• Version Model Number: 611.367.2087-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	07640110981931 [Package]; Contains: 07640110988886; Package: Box [20 Units]; In Commercial Distribution
GS1	07640110988886 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072481

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 [Jet Port Plus II]

• 76401109888866: Jet Port Plus II HP PUR Kit with 8F x 750 mm Pre-attached Polyurethane Catheter and Silicone Plu
• 76401109888798: Jet Port Plus II HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
• 76401109888552: Jet Port Plus II HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Plu
• 76401109879406: Jet Port Plus II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
• 07640110981931: Jet Port Plus II HP PUR Kit with 8F x 750 mm Pre-attached Polyurethane Catheter and Silicone Plu
• 07640110982167: Jet Port Plus II HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
• 07640110982174: Jet Port Plus II HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Plu
• 07640110981702: Jet Port Plus II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
• 00813623010727: 8F Jet Port Plus II HP PUR Kit