Tita Jet Light II

GUDID 07640110982198

Tita Jet Light II HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs

PFM MEDICAL INCORPORATED

Vascular port/catheter

• Primary Device ID: 07640110982198
• NIH Device Record Key: 21294a47-8b91-44f3-991d-e501c365a52f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tita Jet Light II
• Version Model Number: 616.368.3077-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	07640110982198 [Package]; Contains: 07640110988930; Package: Box [20 Units]; In Commercial Distribution
GS1	07640110988930 [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 [Tita Jet Light II]

• 76401109889542: Tita Jet Light II HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plug
• 76401109889306: Tita Jet Light II HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Pl
• 76401109879888: Tita Jet Light II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
• 07640110982181: Tita Jet Light II HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plug
• 07640110982198: Tita Jet Light II HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Pl
• 07640110981757: Tita Jet Light II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter