AMARA 1090211

GUDID 00606959012851

AMARA MASK WITH RS FRAME WITHOUT HEADGEAR DOM, SMALL

Respironics, Inc.

CPAP/BPAP face mask, reusable
Primary Device ID00606959012851
NIH Device Record Key5211b54b-7eb4-425f-b335-dad8bf1a24f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMARA
Version Model Number00
Catalog Number1090211
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 Usefalse
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
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 HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959012851 [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 Date2018-11-12
Device Publish Date2016-06-10

On-Brand Devices [AMARA]

0060695902297300
0060695902296600
0060695902295900
00606959015036AMARA MASK SE WITH RS FRAME AND HEADGEAR INTL, LARGE
00606959015029AMARA MASK SE WITH RS FRAME AND HEADGEAR INTL, MEDIUM
00606959015012AMARA MASK SE WRS FRAME AND RS HEADGEAR INTL, SMALL
00606959015005AMARA MASK SE WRS FRAME AND RS HEADGEAR INTL, PETITE
00606959014992AMARA MASK WITH RS FRAME AND HEADGEAR INTL, LARGE
00606959014985AMARA MASK WITH RS FRAME AND HEADGEAR INTL, MEDIUM
00606959014978AMARA MASK WITH RS FRAME AND RS HEADGEAR INTL, SMALL
00606959014961AMARA MASK WITH RS FRAME AND RS HEADGEAR INTL, PETITE
00606959014459AMARA STARTER KIT, PETITE
00606959014374AMARA MASK WITH RS FRAME WITHOUT HEADGEAR DOM, PETITE
00606959013902Amara FitPack
00606959012899AMARA MASK WITH RS FRAME WITHOUT HEADGEAR DOM, MEDIUM
00606959012851AMARA MASK WITH RS FRAME WITHOUT HEADGEAR DOM, SMALL
00606959012653AMARA MASK WITH RS FRAME AND HEADGEAR DOM, LARGE
00606959012646AMARA MASK WITH RS FRAME AND HEADGEAR DOM, MEDIUM
0060695900932500
00606959007192AMARA HEADGEAR - RP
00606959007185AMARA HEADGEAR, RS, RP
00606959007154AMARA CUSHION, RP-LARGE
00606959007147AMARA CUSHION, RP-MEDIUM
00606959007130AMARA CUSHION, RP - SMALL
00606959007123AMARA CUSHION, RP - PETITE
00606959006508AMARA MASK WITH RS FRAME AND RS HEADGEAR DOM, SMALL
00606959006492AMARA MASK W RS FRAME AND RS HEADGEAR DOM, PETITE
00606959025219AMARA MASK SE WITH RS FRAME AND HEADGEAR CHINA, LARGE
00606959025202AMARA MASK SE WITH RS FRAME AND HEADGEAR CHINA, MEDIUM
00606959025196AMARA MASK SE WITH RS FRAME AND RS HEADGEAR CHINA, SMALL
00606959025189AMARA MASK SE WITH RS FRAME AND RS HEADGEAR CHINA, PETITE
00606959025172AMARA MASK WITH RS FRAME AND HEADGEAR CHINA, LARGE
00606959025165AMARA MASK WITH RS FRAME AND HEADGEAR CHINA, MEDIUM
00606959025158AMARA MASK WITH RS FRAME AND HEADGEAR CHINA, SMALL
00606959025141AMARA MASK WITH RS FRAME AND HEADGEAR CHINA, PETITE
00606959025134AMARA MASK SE WITH RS FRAME AND HEADGEAR JPN, LARGE
00606959025127AMARA MASK SE WITH RS FRAME AND HEADGEAR JPN, MEDIUM
00606959025110AMARA MASK SE WITH RS FRAME AND RS HEADGEAR JPN, SMALL
00606959025103AMARA MASK SE WITH RS FRAME AND RS HEADGEAR JPN, PETITE
00606959025097AMARA MASK WITH RS FRAME AND HEADGEAR JPN, LARGE
00606959025080AMARA MASK WITH RS FRAME AND HEADGEAR JPN, AMARA
00606959025073AMARA MASK WITH RS FRAME AND RS HEADGEAR JPN, SMALL
00606959025066AMARA MASK WITH RS FRAME AND RS HEADGEAR JPN, PETITE
00606959024946AMARA STARTER KIT, LARGE
00606959024939AMARA STARTER KIT, MEDIUM
00606959024922AMARA STARTER KIT, SMALL
00606959024892AMARA MASK WITH RS FRAME WITHOUT HEADGEAR DOM, LARGE
00606959024748Amara View Mask with headgear, XS, Japan

Trademark Results [AMARA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AMARA
AMARA
98365564 not registered Live/Pending
Perfume Attraction LLC
2024-01-19
AMARA
AMARA
98124496 not registered Live/Pending
BioConsortia, Inc.
2023-08-09
AMARA
AMARA
97339983 not registered Live/Pending
Khatchadoorian, Karekin
2022-03-31
AMARA
AMARA
90874565 not registered Live/Pending
Branson, Shemika
2021-08-10
AMARA
AMARA
90570981 not registered Live/Pending
Amara LLC
2021-03-10
AMARA
AMARA
88440295 not registered Live/Pending
Echols, Daniel David
2019-05-21
AMARA
AMARA
88077995 not registered Live/Pending
Proteína Animal, S.A. de C.V.
2018-08-14
AMARA
AMARA
87719816 5519014 Live/Registered
ALRA 05 LLC
2017-12-13
AMARA
AMARA
87254641 not registered Live/Pending
Amara Living Limited
2016-12-02
AMARA
AMARA
87174402 not registered Dead/Abandoned
Quoc N. Tran
2016-09-16
AMARA
AMARA
87060735 5297538 Live/Registered
TRANSFORM SR BRANDS LLC
2016-06-06
AMARA
AMARA
86869800 5167813 Live/Registered
Crowns Of The People, Inc.
2016-01-08

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