Innospire Go 1126586

GUDID 00383730004204

ISG HANDSET AND MOUTHPIECE ASSY KOREA

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Ultrasonic nebulizing system
Primary Device ID00383730004204
NIH Device Record Keye23bb500-6012-44f6-a183-387e4556f0cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameInnospire Go
Version Model Number00
Catalog Number1126586
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 Batchfalse
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)744-2500
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)744-2500
EmailRESPIRONICS.SERVICE@PHILIPS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100383730004204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNEBULIZER (DIRECT PATIENT INTERFACE)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-10
Device Publish Date2018-11-09

On-Brand Devices [Innospire Go]

00383730004204ISG HANDSET AND MOUTHPIECE ASSY KOREA
00383730003870Innopsire Go Mask Adapter
00383730003863ACDC Power Adapter (UK)
00383730003856AC DC Power Adapter (US)

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