CoughAssist 325-9237

GUDID 00606959021600

CoughAssist, Patient Circuit, Infant

Respironics, Inc.

Mechanical positive pressure airway secretion-clearing device
Primary Device ID00606959021600
NIH Device Record Key634e7223-b19e-410f-b6bd-3140ab741467
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoughAssist
Version Model Number00
Catalog Number325-9237
Company DUNS080728314
Company NameRespironics, Inc.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959021600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHJDEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

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 Date2016-09-23

On-Brand Devices [CoughAssist]

00606959021617CoughAssist, Mouthpiece with breathing house and filter
00606959021600CoughAssist, Patient Circuit, Infant
00606959021594CoughAssist, Patient Circuit, Toddler
00606959021419CoughAssist 70 Series, Mouthpiece
00606959021396CoughAssist 70 Series, Water Trap
00606959021372CoughAssist 70 Series Circuit, Mouthpiece, 9ft
00606959021365CoughAssist 70 Series Circuit, Adult Large, 9ft
00606959021358CoughAssist 70 Series Circuit, Adult Medium, 9ft
00606959021341CoughAssist 70 Series Circuit, Adult Small, 9ft
00606959021334CoughAssist 70 Series Circuit, Toddler 9ft
00606959021327CoughAssist 70 Series Circuit, Infant, 9ft.
00606959021259CoughAssist 70 Series Circuit, Mouthpiece, 6ft
00606959021242CoughAssist 70 Series Circuit, Trach, 6ft
00606959021235CoughAssist 70 Series Circuit, Adult Large, 6ft
00606959021228CoughAssist 70 Series Circuit, Adult Medium, 6ft
00606959021211CoughAssist 70 Series Circuit, Adult Small, 6 ft
00606959021204CoughAssist 70 Series, Toddler Circuit, 6ft
00606959021198CoughAssist 70 Series, Circuit, Infant, 6ft
00606959020498CoughAssist, Infant Face Mask
00606959015289CoughAssist, Adapter, 22mm x 15mm
00606959006737CoughAssist, Disposable Filter
00606959006720CoughAssist, Patient Circuit, Trach
00606959006713CoughAssist, Adult Facemask, Large, with hose, filter, and adapter
00606959006706CoughAssist Patient Circuit, Medium
00606959006690CoughAssist, Patient Circuit, Small
00606959005570CoughAssist, E70, Japan
00606959005563CoughAssist, E70, China
00606959005556CoughAssist, E70, Brazil
00606959005549CoughAssist, T70
00606959005532CoughAssist, E70 International
00606959043091CoughAssist Adapter 22mm x 22mm
00606959041530CoughAssist, Mouthpiece
00606959041523CoughAssist Circuit Breathing F-EM2CA
00606959041394CoughAssist 70 Series, 6ft clear tube
00606959037472CoughAssist, Toddler Face Mask
00606959037465CoughAssist, Adult Face Mask, Small
00606959037458CoughAssist, Adult FaceMask, Medium
00606959037441CoughAssist, Adult Face Mask, Large
00606959037427CoughAssist 70 Series Circuit, Trach, 9ft
00606959047143SMOOTH BORE TUBE, 22MM X 36"
00606959044128Sapio, EasyCough
0060695905847700

Trademark Results [CoughAssist]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COUGHASSIST
COUGHASSIST
76614948 3078219 Live/Registered
RIC INVESTMENTS, LLC.
2004-10-06

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