ComboMap Pressure and Flow System 80745001

GUDID 00084522501874

VOLCANO CORPORATION

Intravascular haemodynamic monitoring system
Primary Device ID00084522501874
NIH Device Record Key44758c28-79b3-49d4-9e2b-63583f3d5c66
Commercial Distribution StatusIn Commercial Distribution
Brand NameComboMap Pressure and Flow System
Version Model Number6800
Catalog Number80745001
Company DUNS135179237
Company NameVOLCANO CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does n
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100084522501874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBJCatheter, Ultrasound, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-08

On-Brand Devices [ComboMap Pressure and Flow System ]

000845225018746800
008452250108746800

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