Vital Signs Monitor

GUDID 06944413807808

Edan Instruments, Inc.

Single-patient intensive/general healthcare physiologic monitoring system
Primary Device ID06944413807808
NIH Device Record Keyb2c38718-ec07-4b6f-96c7-c342f8aa7fc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameVital Signs Monitor
Version Model NumberMM3
Company DUNS529173163
Company NameEdan Instruments, Inc.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944413807808 [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 Date2020-02-06
Device Publish Date2016-09-13

On-Brand Devices [Vital Signs Monitor]

06944413808812iM3
06944413807808MM3
06944413807716VSM-300B
06944413806689VSM-300A
06944413806672VSM-300
06944413800786M3A
06944413800625M3B
06944413800618M3
06944413813465iHM3s
06944413813458iM3Bs
06944413813441iM3As
06944413811171iM3s

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