GUDID 00840682103015

GE Healthcare Finland Oy

Patient monitoring system module, cardiac output
Primary Device ID00840682103015
NIH Device Record Key4085cb7d-1bad-4f69-9081-003d48917b43
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPiCCO Injectate Sensor Cable
Company DUNS401966697
Company NameGE Healthcare Finland Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)558-5120
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682103015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXGCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

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 Date2016-06-10

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00195278093998 - PORTRAIT HUB012023-09-11 HUB, AMBULATORY HUB DEVICE ASSEMBLY
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