Duns Number:769934225
Catalog Number
-
Brand Name
Inogen
Version/Model Number
3700/02BAUD001/0001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K040712,K040712,K040712
Product Code
MOD
Product Code Name
Accessory To Continuous Ventilator (Respirator)
Public Device Record Key
e7ef5b77-72ea-458a-8590-2cae759b831c
Public Version Date
September 22, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
35060120952555
Quantity per Package
200
Contains DI Package
25060120952558
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 17 |