Jet Port Plus

GUDID 07640110981788

Jet Port Plus Silicone Kit HF with 8.4F x 750 mm Attachable Silicone Catheter

PFM MEDICAL INCORPORATED

Vascular port/catheter
Primary Device ID07640110981788
NIH Device Record Key3be3f8b2-ddd6-41c9-a031-e9cf7c77ba43
Commercial Distribution StatusIn Commercial Distribution
Brand NameJet Port Plus
Version Model Number616.463.1080-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
Emailregulatory@pfmmedicalusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107640110981788 [Package]
Contains: 07640110987643
Package: Box [20 Units]
In Commercial Distribution
GS107640110987643 [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 [Jet Port Plus]

76401451102528Jet Port Dual HP PUR Kit with 9.6F x 500 mm Attachable Polyurethane Catheter and Silicone Plugs
76401451102450Jet Port Dual HP PUR Kit with 9.6F x 500 mm Pre-attached Polyurethane Catheter and Silicone Plug
76401451102146Jet Port Dual HP PUR Kit with 9.6F x 500 mm Attachable Polyurethane Catheter
76401451102078Jet Port Dual HP PUR Kit with 9.6F x 500 mm Pre-attached Polyurethane Catheter
76401109888170Jet Port Plus HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter
76401109876436Jet Port Plus Silicone Kit HF with 8.4F x 750 mm Attachable Silicone Catheter
76401109875064Jet Port Plus PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
76401109854892Jet Port Plus HP PUR Kit with 6.6F x 750 mm Pre-attached Polyurethane Catheter
07640110981993Jet Port Dual HP PUR Kit with 9.6F x 500 mm Attachable Polyurethane Catheter and Silicone Plugs
07640110981894Jet Port Dual HP PUR Kit with 9.6F x 500 mm Pre-attached Polyurethane Catheter and Silicone Plug
07640110981948Jet Port Dual HP PUR Kit with 9.6F x 500 mm Attachable Polyurethane Catheter
07640110981801Jet Port Dual HP PUR Kit with 9.6F x 500 mm Pre-attached Polyurethane Catheter
07640110982099Jet Port Plus HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter
07640110981788Jet Port Plus Silicone Kit HF with 8.4F x 750 mm Attachable Silicone Catheter
07640110981283Jet Port Plus PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
07640110981917Jet Port Plus HP PUR Kit with 6.6F x 750 mm Pre-attached Polyurethane Catheter

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