Tita Jet Light II 616.368.2080-A

GUDID 76401109879888

Tita Jet Light II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter

PFM MEDICAL INCORPORATED

Infusion/injection port, implantable

• Primary Device ID: 76401109879888
• NIH Device Record Key: 0e0f1bf0-6c56-44a8-87f8-455c9194ac00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tita Jet Light II
• Version Model Number: 616.368.2080-A
• Catalog Number: 616.368.2080-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	76401109879888 [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 [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