Alice NightOne 1134120

GUDID 00606959047327

Alice NightOne, Brazil, Flow Gen

Respironics, Inc.

Polysomnograph
Primary Device ID00606959047327
NIH Device Record Keyaeaad44a-6264-4a3f-9f4d-42749b82ce13
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlice NightOne
Version Model Number00
Catalog Number1134120
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 Batchfalse
Serial Numbertrue
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959047327 [Primary]

FDA Product Code

MNRVENTILATORY EFFORT RECORDER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-11

On-Brand Devices [Alice NightOne]

00606959050891Alice NightOne, Korea, Wireless Flow Gen
00606959050877Alice NightOne, Korea
00606959049406Alice NightOne Wireless, China
00606959049390Alice NightOne Wireless, China
00606959048089Alice NightOne, Brazil
00606959047396Alice NightOne, International
00606959047389Alice NightOne, International Wireless, Masimo
00606959047372Alice NightOne, Wireless, Intl
00606959047365Alice NightOne Home Diagnostic System, Wireless, U.S./North America
00606959047358Alice NightOne Home Diagnostic System, North America, Masimo oximetry, Wireless
00606959047341Alice NightOne System, Wireless, North America, Nonin
00606959047334Alice NightOne Brazil
00606959047327Alice NightOne, Brazil, Flow Gen
00606959039841Alice NightOne North America, Warranty Wireless
00606959039834Alice NightOne International Warranty (Non-Wireless)
00606959039827Alice NightOne International Warranty Wireless
00606959039810Alice NightOne, North America, Wireless
00606959039803Alice NightOne International (Non-Wireless)
00606959039797Alice NightOne International Wireless
00606959039728Alice NightOne Nonin SpO2 Assembly
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