Jet Port Plus II

GUDID 07640110981931

Jet Port Plus II HP PUR Kit with 8F x 750 mm Pre-attached Polyurethane Catheter and Silicone Plugs

PFM MEDICAL INCORPORATED

Vascular port/catheter
Primary Device ID07640110981931
NIH Device Record Key1a4e48f6-7f09-41cf-8b52-d3026e9dad31
Commercial Distribution StatusIn Commercial Distribution
Brand NameJet Port Plus II
Version Model Number611.367.2087-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
GS107640110981931 [Package]
Contains: 07640110988886
Package: Box [20 Units]
In Commercial Distribution
GS107640110988886 [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 II]

76401109888866Jet Port Plus II HP PUR Kit with 8F x 750 mm Pre-attached Polyurethane Catheter and Silicone Plu
76401109888798Jet Port Plus II HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
76401109888552Jet Port Plus II HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Plu
76401109879406Jet Port Plus II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
07640110981931Jet Port Plus II HP PUR Kit with 8F x 750 mm Pre-attached Polyurethane Catheter and Silicone Plu
07640110982167Jet Port Plus II HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
07640110982174Jet Port Plus II HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Plu
07640110981702Jet Port Plus II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
008136230107278F Jet Port Plus II HP PUR Kit

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