Duns Number:004239034
Device Description: iNX for iNLine, Integrated Patient Transport & Loading System – SX
Catalog Number
-
Brand Name
iNX
Version/Model Number
0015812
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 26, 2019
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPO
Product Code Name
Stretcher, Wheeled
Public Device Record Key
fceb119c-8a1d-46a1-b633-23ab68454882
Public Version Date
August 30, 2022
Public Version Number
3
DI Record Publish Date
February 13, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 140 |