N/A

GUDID 00840682120104

GE Healthcare Finland Oy

Frame/rail/pole device holder
Primary Device ID00840682120104
NIH Device Record Key2dd19c8a-faa9-4096-b0e6-8080a2a3dfc0
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberM1051023
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682120104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2017-04-11

On-Brand Devices [N/A]

00840682120104M1051023
00840682120098M1051025
00840682119832M1049197
00840682137829ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD W
00840682140799ECG LEADWIRE SET, 5-LD, GRABBER, AHA, 74 CM/ 29 IN
00840682140522ECG Leadwire set, 6-lead, grouped, grabber, AHA, 7
00840682140508ECG Leadwire set, 3-lead, snap, IEC, 130 cm/ 51 in
00840682140478ECG Leadwire set, 5-lead C2-6, snap, IEC, 130 cm/
00840682140461ECG Leadwire set, 6-lead, grouped, grabber, AHA, 1
00840682140430DIN Converter, 3-lead
00840682140409ECG Leadwire set, 6-lead, grouped, snap, IEC, 130
00840682140393ECG Leadwire set, 5-lead C2-6, snap, IEC, 74 cm/ 2
00840682140379ECG Leadwire set, 6-lead, grouped, snap, IEC, 74 c
00840682140355DIN Converter, 12-lead Kit
00840682140348ECG Leadwire set, 5-lead, grabber, AHA, mix 74 cm/
00840682140317ECG Leadwire set, 3-lead, grabber, IEC, 130 cm/ 51
00840682140287ECG Leadwire set, 5-lead V2-6, grabber, AHA, 130 c
00840682140256ECG Leadwire set, 6-lead, grouped, grabber, IEC, 1
00840682140232ECG Leadwire set, 3-lead, grabber, AHA, 130 cm/ 51
00840682140201ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in
00840682140171ECG Leadwire set, 5-lead, grouped, snap, IEC, 130
00840682140157DIN Converter, 5-lead
00840682140133ECG Leadwire set, 5-lead, grabber, IEC, mix 74 cm/
00840682140126ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 c
00840682140119ECG Leadwire set, 3-lead, snap, AHA, 130 cm/ 51 in
00840682140102ECG Leadwire set, 5-lead V2-6, snap, AHA, 74 cm/ 2
00840682140096ECG Leadwire set, 5-lead, grouped, snap, AHA, 130
00840682140089ECG Leadwire set, 5-lead, grouped, grabber, IEC, 1
00840682140072ECG Leadwire set, 6-lead, grouped, grabber, IEC, 7
00840682140058ECG Leadwire set, 3-lead, grabber, IEC, 74 cm/ 29
00840682140041ECG Leadwire set, 6-lead, grouped, grabber, AHA, m
00840682140034ECG Leadwire set, 5-lead, grouped, snap, AHA, mix
00840682140003ECG Leadwire set, 5-lead, grabber, IEC, 74 cm/ 29
00840682139984ECG Leadwire set, 5-lead, grouped, grabber, IEC, m
00840682139960ECG Leadwire set, 5-lead, grouped, grabber, AHA, 7
00840682139953ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in
00840682139939ECG Leadwire set, 5-lead, snap, IEC, 130 cm/ 51 in
00840682139922ECG Leadwire set, 5-lead C2-6, grabber, IEC, 130 c
00840682139892ECG Leadwire set, 5-lead V2-6, snap, AHA, 130 cm/
00840682139885ECG Leadwire set, 5-lead V2-6, grabber, AHA, 74 cm
00840682139854ECG Leadwire set, 5-lead, snap, AHA, mix 74 cm/ 29
00840682139847ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in
00840682139830ECG Leadwire set, 5-lead, grabber, AHA, 130 cm/ 51
00840682139823ECG Leadwire set, 5-lead C2-6, grabber, IEC, 74 cm
00840682139816ECG Leadwire set, 5-lead, grouped, snap, IEC, mix
00840682139786ECG Leadwire set, 5-lead, grouped, grabber, AHA, m
00840682139779ECG Leadwire set, 5-lead, grouped, grabber, AHA, 1
00840682139724ECG Leadwire set, 3-lead, snap, IEC, 74 cm/ 29 in
00840682139717ECG Leadwire set, 6-lead, grouped, grabber, IEC, m
00840682139700ECG Leadwire set, 5-lead, grouped, grabber, IEC, 7

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