InnoSpire Elegance 1127600

GUDID 00383730003481

Innospire Elegance, Custom Norcal Resp, 6 pack.

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Nebulizing system, non-heated Nebulizing system, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated
Primary Device ID00383730003481
NIH Device Record Keybfe33f89-94a2-457d-98a6-8a070c101e94
Commercial Distribution StatusIn Commercial Distribution
Brand NameInnoSpire Elegance
Version Model Number00
Catalog Number1127600
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
GS100383730003481 [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

On-Brand Devices [InnoSpire Elegance]

00383730004150CUSTOM ELEGANCE CHILDRENS HOSPITAL.
00383730004112ELEGANCE WITH SSR (RUSSIA)
00383730003481Innospire Elegance, Custom Norcal Resp, 6 pack.
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00383730003382Innospire Elegance, Custom Rochester Oxygen, 6 pack.
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00383730003290Innospire Elegance, Custom Baycare Homecare, 6 pack.
00383730003283Innospire Elegance, Custom New Hope Medical Supplies, 6-pack
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00383730003252Innospire Elegance, Custom Wheelock, 6-pack
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00383730003214Innospire Elegance, Custom Allmed, 6-pack
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00383730003184Innospire Elegance, Custom Personal Support, 6-pack
00383730003177Innospire Elegance, Custom OSF Home Care Service, 6 pack.
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00383730003153Innospire Elegance, Custom Fidelity Health, 6 pack.
00383730003146Innospire Elegance, Custom Seeley Medical, 6-pack
00383730003139Innospire Elegance, Custom Today's Resp, 6 pack.
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