Jet Port Plus II 616.367.2080-A

GUDID 76401109879406

Jet Port Plus II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter

PFM MEDICAL INCORPORATED

Infusion/injection port, implantable

• Primary Device ID: 76401109879406
• NIH Device Record Key: 7d3f9b8b-3cb8-493c-9231-eb91702faa84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jet Port Plus II
• Version Model Number: 616.367.2080-A
• Catalog Number: 616.367.2080-A
• 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: customerservice@pfmmedicalusa.
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.

Device Identifiers

Device Issuing Agency	Device ID
GS1	76401109879406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000125

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-23

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