COMFORTGEL 1081872

GUDID 00606959022270

Respironics, Inc.

CPAP/BPAP face mask, reusable
Primary Device ID00606959022270
NIH Device Record Key6ead9985-b25e-45e6-bf6c-7c2fd18861cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMFORTGEL
Version Model Number00
Catalog Number1081872
Company DUNS080728314
Company NameRespironics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does n
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.co

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959022270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2018-08-20
Device Publish Date2015-11-06

On-Brand Devices [COMFORTGEL]

0060695902227000
0060695902225600
0060695902224900
0060695902223200
0060695902222500
0060695902221800
0060695902220100
0060695902219500
0060695902216400
0060695902215700
00606959022140Nasal Mask
0060695902213300
0060695902108200
0060695902107500
0060695902106800
0060695902105100
0060695902104400
0060695902103700
0060695902102000
0060695902083200
0060695902082500
0060695902081800
0060695901540100
0060695901538800
0060695901537100
0060695901388900
00606959007062Full Face Mask
0060695900705500
0060695900704800
0060695900703100
0060695900656000
0060695900655300
0060695900654600
0060695900653900
0060695900433700
0060695900432000
0060695900431300
0060695900430600
0060695900429000
0060695900428300
0060695900427600
0060695900426900
0060695900160200
0060695900159600
0060695900158900
00606959001572Comfort Gel Blue Nasal Mask with headgear, L, International

Trademark Results [COMFORTGEL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COMFORTGEL
COMFORTGEL
90673803 not registered Live/Pending
Keeco, LLC
2021-04-27
COMFORTGEL
COMFORTGEL
85547190 4296463 Live/Registered
Corona Clipper, Inc.
2012-02-20
COMFORTGEL
COMFORTGEL
78200616 2841802 Live/Registered
AMEDA, INC.
2003-01-07
COMFORTGEL
COMFORTGEL
75726548 2488596 Dead/Cancelled
SADDLEMAN, INC.
1999-06-10
COMFORTGEL
COMFORTGEL
75711040 2432257 Dead/Cancelled
SADDLEMAN, INC.
1999-05-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.