Engage Medical Device Alarm Notification System (EMDAN) 910-01957

GUDID 00860002177786

STRYKER CORPORATION

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Primary Device ID00860002177786
NIH Device Record Keyb7ad2199-dad6-4743-8823-66f935075cd6
Commercial Distribution StatusIn Commercial Distribution
Brand NameEngage Medical Device Alarm Notification System (EMDAN)
Version Model NumberEMDAN 2.3.1
Catalog Number910-01957
Company DUNS078470558
Company NameSTRYKER CORPORATION
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100860002177786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSXSystem, network and communication, physiological monitors

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-10-05
Device Publish Date2023-01-27

On-Brand Devices [Engage Medical Device Alarm Notification System (EMDAN)]

00860002177786EMDAN 2.3.1
00860002177762EMDAN 2.5.0
00860002177755EMDAN 2.4.0
00860002177748EMDAN 2.3.0
00860002177731EMDAN 2.1.1
00860002177724EMDAN 1.10.0
00860002177717EMDAN 2.2.0
00860002177700EMDAN 2.1.0

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