IEM GmbH

GUDID 04041346100876

Hypertension Management Software

IEM GmbH

Medical equipment clinical data interfacing software
Primary Device ID04041346100876
NIH Device Record Key108a52b0-1278-4189-a2ae-27f454281bee
Commercial Distribution StatusIn Commercial Distribution
Brand NameIEM GmbH
Version Model NumberHMS CS 6.1.3
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104041346100876 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-17
Device Publish Date2021-12-09

On-Brand Devices [IEM GmbH]

04041346100876Hypertension Management Software
04041346102054Hypertension Management Software
04041346102153Hypertension Management Software Version 6
04041346102207Hypertension Management Software Version 6

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