EncorePro2 1099731

GUDID 00606959055001

Software, EncorePro2, web

Respironics, Inc.

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Primary Device ID00606959055001
NIH Device Record Key2c28c8e2-8404-418d-b23f-d13b12b0766f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEncorePro2
Version Model Number2.24
Catalog Number1099731
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
GS100606959055001 [Primary]

FDA Product Code

BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-10
Device Publish Date2019-12-02

On-Brand Devices [EncorePro2]

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

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