SimplyGo Mini 1133944

GUDID 00606959047457

SimplyGoMini, Extended Battery, Japan

Respironics, Inc.

Portable oxygen concentrator
Primary Device ID00606959047457
NIH Device Record Keye4827190-c69e-4501-98f6-18534b8bd6bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimplyGo Mini
Version Model Number00
Catalog Number1133944
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 Latextrue
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 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 TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959047457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAWGenerator, oxygen, portable

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 Date2017-06-07

On-Brand Devices [SimplyGo Mini]

00606959048867SimplyGo Mini,Extd.Battery,Argentina
00606959048850SimplyGo Mini,Stnd.Battery,Argentina
00606959048843SimplyGo Mini,Extended Battery, IT
00606959048836SimplyGo Mini,Standard Battery, IT
00606959048317SimplyGo Mini with 2 Standard Batt.,NA
00606959047457SimplyGoMini, Extended Battery, Japan
00606959047440SimplyGoMini, Standard Battery, Japan
00606959047433SimplyGo Mini Device, Japan
00606959042094SimplyGo Mini Portable Oxygen Concentrator (Extended Battery), Brazil
00606959042087SimplyGo Mini Portable Oxygen Concentrator (with Standard Battery), International
00606959042070SimplyGo Mini Portable Oxygen Concentrator, Brazil
00606959035935SimplyGo Mini,Extended Battery,KO
00606959035836SimplyGo Mini,Standard Battery,KO
00606959035829SimplyGo Mini,Device,KO
00606959033832SimplyGo Mini with Extended Battery, IKK.
00606959033825SimplyGo Mini with Standard Battery, IKK.
00606959033818SimplyGo Mini Device, IKK.
00606959032460SimplyGo Mini, Extended Battery, Saudi Arabia
00606959032453SimplyGo Mini, Standard Battery, Saudi Arabia
00606959032446SimplyGo Mini,Saudi Arabia
00606959032439SimplyGo Mini with Extended Battery, INTL.
00606959032422SimplyGo Mini with Standard Battery, INTL.
00606959032415SimplyGo Mini Device, International.
00606959032408SimplyGo Mini with Extended BAttery, NA.
00606959032392SimplyGo Mini with Standard Battery, NA.
00606959032385SimplyGo Mini Device, North American
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