Inogen At Home Stationary Concentrator GS-100

GUDID 00817131020131

Inogen At Home Stationary Concentrator, NCE (10-05345-XX-XX)

INOGEN, INC.

Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator
Primary Device ID00817131020131
NIH Device Record Key554f244e-5d2e-4067-a60b-4ecb98f915c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameInogen At Home Stationary Concentrator
Version Model NumberNCE
Catalog NumberGS-100
Company DUNS136729634
Company NameINOGEN, 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

Phone805-562-0500
Emailcompliance@inogen.net
Phone805-562-0500
Emailcompliance@inogen.net
Phone805-562-0500
Emailcompliance@inogen.net

Operating and Storage Conditions

Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817131020131 [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 Date2017-03-27

On-Brand Devices [Inogen At Home Stationary Concentrator]

00817131020148Inogen At Home Stationary Concentrator, CE (10-06316-XX-XX)
00817131020131Inogen At Home Stationary Concentrator, NCE (10-05345-XX-XX)

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