InnoSpire Essence 1099967

GUDID 00383730001890

Innospire Essence with SSD 230V 50HZ EU, 6-pack

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Nebulizing system, non-heated
Primary Device ID00383730001890
NIH Device Record Key5b4fe30c-d6d8-4b83-9edf-6288eea245b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameInnoSpire Essence
Version Model Number00
Catalog Number1099967
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 Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100383730001890 [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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00383730001906Innospire Essence Unit Assembly 220V 60HZ (US)
00383730001890Innospire Essence with SSD 230V 50HZ EU, 6-pack
00383730001883Innospire Essence Assembly, EU Plug with 230V 50HZ
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