Stabil-O-Graph

GUDID 04041346020006

IEM GmbH

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID04041346020006
NIH Device Record Key0605abc1-f061-42b1-930b-c5ca37aaba8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameStabil-O-Graph
Version Model Numbermobil
Company DUNS344030150
Company NameIEM GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+49240295000
Emailservice@iem.de
Phone+4924141259300
Emailcustomer.relations@iem.de
Phone+4924141259300
Emailcustomer.relations@iem.de
Phone+4924141259300
Emailcustomer.relations@iem.de
Phone+4924141259300
Emailcustomer.relations@iem.de
Phone+4924141259300
Emailcustomer.relations@iem.de
Phone+4924141259300
Emailcustomer.relations@iem.de
Phone+4924141259300
Emailcustomer.relations@iem.de
Phone+4924141259300
Emailcustomer.relations@iem.de
Phone+4924141259300
Emailcustomer.relations@iem.de
Phone+4924141259300
Emailcustomer.relations@iem.de
Phone+4924141259300
Emailcustomer.relations@iem.de
Phone+4924141259300
Emailcustomer.relations@iem.de
Phone+4924141259300
Emailcustomer.relations@iem.de

Device Identifiers

Device Issuing AgencyDevice ID
GS104041346020006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2017-11-24

Devices Manufactured by IEM GmbH

04041346102207 - IEM GmbH2023-11-08 Hypertension Management Software Version 6
04041346102153 - IEM GmbH2023-08-30 Hypertension Management Software Version 6
04041346102160 - Tel-O-Graph2023-08-30 LTE 4G capable
04041346102269 - Mobil-O-Graph2023-07-10
04041346101354 - Welch Allyn2022-06-09
04041346101392 - Welch Allyn2022-06-09
04041346101415 - Welch Allyn2022-06-09
04041346101439 - Welch Allyn2022-06-09

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