Tita Jet Light

GUDID 07640110982006

Tita Jet Light Dual HP PUR Kit with 9.6F x 500 mm Attachable Polyurethane Catheter

PFM MEDICAL INCORPORATED

Vascular port/catheter

• Primary Device ID: 07640110982006
• NIH Device Record Key: 14a15f64-9747-432d-99c0-6f8257dbbc27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tita Jet Light
• Version Model Number: 616.022.0077-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	07640110982006 [Package]; Contains: 07640145110238; Package: Box [20 Units]; In Commercial Distribution
GS1	07640145110238 [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 ]

• 76401451102764: Tita Jet Light Dual HP PUR Kit with 9.6F x 500 mm Attachable Polyurethane Catheter and Silicone
• 76401451102696: Tita Jet Light Dual HP PUR Kit with 9.6F x 500 mm Pre-attached Polyurethane Catheter and Silicon
• 76401451102382: Tita Jet Light Dual HP PUR Kit with 9.6F x 500 mm Attachable Polyurethane Catheter
• 76401109888934: Tita Jet Light HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter
• 76401109875132: Tita Jet Light PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
• 76401109854724: TJL Low Profile HP PUR Kit with 4.8F x 750 mm Attachable Polyurethane Catheter
• 76401109854656: TJL Low Profile HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter
• 07640110982068: Tita Jet Light Dual HP PUR Kit with 9.6F x 500 mm Attachable Polyurethane Catheter and Silicone
• 07640110981900: Tita Jet Light Dual HP PUR Kit with 9.6F x 500 mm Pre-attached Polyurethane Catheter and Silicon
• 07640110982006: Tita Jet Light Dual HP PUR Kit with 9.6F x 500 mm Attachable Polyurethane Catheter
• 07640110982082: Tita Jet Light HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter
• 07640110981276: Tita Jet Light PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
• 07640110982075: TJL Low Profile HP PUR Kit with 4.8F x 750 mm Attachable Polyurethane Catheter
• 07640110980835: TJL Low Profile HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter