MASK - OC Advanced HS81311

GUDID 00383730001180

OC Advanced Adult Large Mask

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Medicine chamber spacer, reusable
Primary Device ID00383730001180
NIH Device Record Key361387ff-7584-48b3-8728-3c0aa49ff11d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMASK - OC Advanced
Version Model Number00
Catalog NumberHS81311
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 Numberfalse
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
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
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
GS100383730001180 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-24

On-Brand Devices [MASK - OC Advanced]

00383730001203OC Advanced Adult Large Mask, 10-pack
00383730001197Oc Advanced Lark Mask (81310EU), Single Unit
00383730001180OC Advanced Adult Large Mask
00383730001166OC Advanced Medium Pediatric Mask, Single Unit
00383730001159OC Advanced Pediatric Medium Mask
00383730001142OC Advanced Pediatric Small Mask
00383730001135OC Advanced Small Pediatric Mask, Single Unit
00383730001128OC Advanced Pediatric Small Mask

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