GUDID 00840682104074

GE Healthcare Finland Oy

Patient monitoring system module, multiple-gas
Primary Device ID00840682104074
NIH Device Record Key17aa91a9-c716-4a3d-b723-073c47720aae
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberN-CAiO-00
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 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

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
GS100840682104074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, electronic, clinical

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 Date2016-06-03

Devices Manufactured by GE Healthcare Finland Oy

00195278697165 - PORTRAIT HSWXB2024-05-08 Portrait HSWXB Medical Software
00195278713193 - Portrait HUBXB2024-05-08 Portrait Mobile Patient Monitor Hardware HUBXB
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

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