Tita Jet Light 616.362.2080-A

GUDID 76401109875132

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

PFM MEDICAL INCORPORATED

Infusion/injection port, implantable Infusion/injection port, implantable
Primary Device ID76401109875132
NIH Device Record Key92e76ed1-da33-482d-aee5-87d4ba4592e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameTita Jet Light
Version Model Number616.362.2080-A
Catalog Number616.362.2080-A
Company DUNS097736867
Company NamePFM MEDICAL INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7607588749
Emailcustomerservice@pfmmedicalusa.
Phone7607588749
Emailcustomerservice@pfmmedicalusa.

Device Identifiers

Device Issuing AgencyDevice ID
GS176401109875132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJTPort & Catheter, Implanted, Subcutaneous, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-23

On-Brand Devices [Tita Jet Light]

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

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