Care Orchestrator Essence Software 1135709

GUDID 00606959055919

Care Orchestrator Essence, Clinical data collection management information system application software

Respironics, Inc.

Medical equipment clinical data interfacing software
Primary Device ID00606959055919
NIH Device Record Key7cdb7567-7ba8-4eb2-af7c-37cd0f242179
Commercial Distribution StatusIn Commercial Distribution
Brand NameCare Orchestrator Essence Software
Version Model Number2.2
Catalog Number1135709
Company DUNS080728314
Company NameRespironics, 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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100606959055919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBKVENTILATOR, CONTINUOUS, FACILITY USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-04
Device Publish Date2019-08-27

On-Brand Devices [Care Orchestrator Essence Software]

00606959059085Care Orchestrator Essence, Clinical data collection management information system application so
00606959059689Care Orchestrator Essence, Clinical data collection management information system application so
00606959055919Care Orchestrator Essence, Clinical data collection management information system application so
00606959060449Care Orchestrator Essence, Clinical data collection management information system application so

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