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 ID07640110982198
NIH Device Record Key21294a47-8b91-44f3-991d-e501c365a52f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTita Jet Light II
Version Model Number616.368.3077-HA
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
Emailregulatory@pfmmedicalusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107640110982198 [Package]
Contains: 07640110988930
Package: Box [20 Units]
In Commercial Distribution
GS107640110988930 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-06
Device Publish Date2020-02-27

On-Brand Devices [Tita Jet Light II]

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

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