InnoSpire Elegance 1110295

GUDID 00383730003412

Innospire Elegance, Custom McAbee Medical Inc, 6 pack.

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Nebulizing system, non-heated
Primary Device ID00383730003412
NIH Device Record Keycde688b8-4dd3-4769-884f-dd6c4cd7ca22
Commercial Distribution StatusIn Commercial Distribution
Brand NameInnoSpire Elegance
Version Model Number00
Catalog Number1110295
Company DUNS220018415
Company NameRESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100383730003412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTICompressor, air, portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-24

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