VETA Peritoneal Dialysis Catheter M7230

GUDID 20813623019243

VETA Peritoneal Dialysis Introducer Kit

PFM MEDICAL INCORPORATED

Peritoneal dialysis catheter, acute/chronic Peritoneal dialysis catheter, acute/chronic Peritoneal dialysis catheter, acute/chronic
Primary Device ID20813623019243
NIH Device Record Keya0f8928e-0024-4f24-acda-8e7d3008e07f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVETA Peritoneal Dialysis Catheter
Version Model NumberM7230
Catalog NumberM7230
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
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813623019249 [Primary]
GS110813623019246 [Package]
Contains: 00813623019249
Package: [5 Units]
In Commercial Distribution
GS120813623019243 [Package]
Contains: 10813623019246
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FJSCatheter, Peritoneal, Long-Term Indwelling
PPJPeritoneal Dialysis Administration Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-05
Device Publish Date2015-10-15

On-Brand Devices [VETA Peritoneal Dialysis Catheter]

10813623040523VETA Peritoneal Dialysis Stylet
20813623019243VETA Peritoneal Dialysis Introducer Kit
10813623016092VETA Peritoneal Dialysis Catheter
10813623016085VETA Peritoneal Dialysis Catheter
10813623016078VETA Peritoneal Dialysis Catheter
20813623015702VETA Peritoneal Catheter Kit, Curled

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.