EncorePro2 1054785

GUDID 00606959053793

EncorePro 2, Software (DVD)

Respironics, Inc.

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Primary Device ID00606959053793
NIH Device Record Key790cdb2f-0148-4b4b-b004-0175700192f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameEncorePro2
Version Model Number2.23
Catalog Number1054785
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
GS100606959053793 [Primary]

FDA Product Code

MNSVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-29
Device Publish Date2018-10-29

On-Brand Devices [EncorePro2]

00606959053793EncorePro 2, Software (DVD)
00606959053786EncorePro2 Software (Web)
00606959055001Software, EncorePro2, web

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