DeVilbiss 9354DR

GUDID 00853040002806

FlexSet Comfort Touch Silicone mask size M

DEVILBISS HEALTHCARE LLC

CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use
Primary Device ID00853040002806
NIH Device Record Key490ad964-28a0-47c1-838d-21d625b43111
Commercial Distribution Discontinuation2016-09-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDeVilbiss
Version Model Number9354DR
Catalog Number9354DR
Company DUNS962175894
Company NameDEVILBISS HEALTHCARE LLC
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

Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com
Phone1-800-338-1988
Emailsomdhccustomerservice@devilbisshc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100853040002806 [Primary]
GS100853040002806 [Primary]
GS100853040002806 [Primary]
GS100853040002806 [Primary]
GS100853040002806 [Primary]
GS100853040002806 [Primary]
GS100853040002806 [Primary]
GS100853040002806 [Primary]
GS100853040002806 [Primary]
GS100853040002806 [Primary]
GS100853040002806 [Primary]
GS100853040002806 [Primary]
GS100853040002806 [Primary]
GS100853040002806 [Primary]
GS100853040002806 [Primary]

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)
BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-06-23
Device Publish Date2016-09-24

On-Brand Devices [DeVilbiss]

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00088530400716FlexSet Mask, Silicone - Medium
00088530400679Serenity Mask, Silicone - Medium
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00088530400259Serenity Mask, ComfortTouch, Gel - Medium
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00088530400099VACU-AIDE COMPACT Spencer, power supply, 12 V Cord
00088530400082Glass Powder Blower
00088530400044SLEEP CUBE AUTO PLUS NORTHERN EUROPE
000885304000335-liter oxygen concentrator
0008530402247310-liter oxygen concentrator (international Model)
00085304008798IntelliPAP AutoBilevel w/HH & HT&SmartLink Module&Data Card
00085304003779Heater, Humidifier
00085304002635E CYL W/IFILL POST ADAPTER, W/870 POST VALVE
00085304002338Homecare Suction, North America
00085304001508Compressor / Nebulizer JCMH Home Health Products
00085304000280FlexSet Comfort Touch Silicone mask size M
00885394001164IntelliPAP Standard w/HH & SmartLink Module & Data Card
0088530402246610-liter oxygen concentrator
00885304022312Vacu-Aide QSU w batterty, Latin America
00885304022305Vacu-Aide QSU, Latin America
00885304022299Vacu-Aide Homecare Suction Unit w/Battery, Latin America
00885304022282Vacu-Aide Homecare Suction Unit, Latin America
01008530402265Compressor/nebulizer
10885304022159IntelliPAP AutoBilevel w/HH - Latin America
10885304022142IntelliPAP Bilevel S w/HH - Latin America
10885304022135IntelliPAP AutoAdjust with Heated Humidifier - Latin America
10885304022128IntelliPAP Standard Plus w/HH - Latin America
10885304022111IntelliPAP Standard with Heated Humidifier - Latin America
10885304022104IntelliPAP auto bilevel - Latin America
10885304022098IntelliPAP Bilevel S - Latin America
10885304022081IntelliPAP Auto Adjust - Latin America
10885304022074IntelliPAP Standard - Latin America
00885304020936D CYL W/IFILL POST ADAPTER, W/870 POST VALVE CANADA
00885304020929C CYL W/IFILL POST ADAPTER, W/870 POST VALVE CANADA
00885304020912M6 CYL W/IFILL POST ADAPTER, W/870 POST VALVE CANADA
00885304020875DeVilbiss Blue AutoPlus (Rest of World)
00885304009238IntelliPAP 2 Standard Plus CPAP - EUROPE
00885304020851DEVILBISS BLUE STANDARD PLUS CPAP REST OF WORLD
0085304009443DeVilbiss Blue Auto Plus CPAP
00885304012252Oxygen PulseDose Conserver - I
00885304011903Oxygen PulseDose Conserver - G
00885304011125ML6 CYL W/CF REG FOR CANADA
00885304011026ML6 CYLINDER W/CF REG EUROPE
00885304010074M6 CYL W/IFILL POST ADAPTER, W/870 POST VALVE
008853040096895-liter oxygen concentrator - Quiet Unit
00885304009634Disposable Suction Canister for Japan
00885304009535IntelliPAP AutoBilevel w/HH & SmartLink II, Module & Data Ca
00885304009528IntelliPAP Bilevel S w/HH & SmartLink II, Module & Data Card

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