Intesys Clinical Suite 92881

GUDID 10841522123627

PRINT MANAGER,92881

SPACELABS HEALTHCARE (WASHINGTON), INC

Medical equipment clinical data interfacing software
Primary Device ID10841522123627
NIH Device Record Key2fc96b59-fe1f-4a5d-be1b-95d05782e0bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntesys Clinical Suite
Version Model NumberSmart Disclosure
Catalog Number92881
Company DUNS145581588
Company NameSPACELABS HEALTHCARE (WASHINGTON), INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522123627 [Primary]

FDA Product Code

DSFRECORDER, PAPER CHART

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-08-18
Device Publish Date2018-08-08

On-Brand Devices [Intesys Clinical Suite]

10841522123580SMART DISCLOSURE,92810
10841522123658ENTERPRISE NETWORK INTERFACE,92848
10841522123627PRINT MANAGER,92881
10841522123610VITAL SIGNS VIEWER,92880
1084152212360312 LEAD ECG INTERFACE,92877
10841522123597CUSTOM TRENDS,92876

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