GUDID 00840682116800

GE Healthcare Finland Oy

Image display monitor mount
Primary Device ID00840682116800
NIH Device Record Key20bc5b31-c8cc-4e56-a90b-5aa4eb077b50
Commercial Distribution StatusIn Commercial Distribution
Version Model Number2069156-001
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

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682116800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ORTBurst suppression detection software for electroencephalograph

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 Date2016-06-30

Devices Manufactured by GE Healthcare Finland Oy

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00195278229229 - PORTRAIT RRP012024-01-03 BODY-WORN RESP ELECTRODE PATCH
00195278699916 - PORTRAIT AAB012023-11-03 Portrait AAB01 SpO2 attachment accessory band, PKG of 30 PCS
00195278699923 - PORTRAIT MMP012023-11-03 Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS
00195278093998 - PORTRAIT HUB012023-09-11 HUB, AMBULATORY HUB DEVICE ASSEMBLY
00195278094001 - PORTRAIT BCH012023-09-11 CHARGER, AMBULATORY CHARGER FINAL DEVICE ASSEMBLY
00195278110435 - PORTRAIT MMP012023-09-11 Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS

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