Primary Device ID | 00817131020148 |
NIH Device Record Key | 43a1459c-188b-4736-bf5f-33e3b847bd83 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Inogen At Home Stationary Concentrator |
Version Model Number | CE |
Catalog Number | GS-100 |
Company DUNS | 136729634 |
Company Name | INOGEN, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 805-562-0500 |
compliance@inogen.net | |
Phone | 805-562-0500 |
compliance@inogen.net | |
Phone | 805-562-0500 |
compliance@inogen.net |
Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817131020148 [Primary] |
CAW | Generator, Oxygen, Portable |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-03-27 |
00817131020148 | Inogen At Home Stationary Concentrator, CE (10-06316-XX-XX) |
00817131020131 | Inogen At Home Stationary Concentrator, NCE (10-05345-XX-XX) |