Duns Number:514619238
Device Description: The NIO-A device is indicated to provide intraosseous access into the proximal tibia and p The NIO-A device is indicated to provide intraosseous access into the proximal tibia and proximal humeral head, in adult patients older than 12 years.
Catalog Number
-
Brand Name
NIO
Version/Model Number
NIO-A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142086,K142086
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
ea3c1d2d-499c-481e-9d65-e998b3d9edba
Public Version Date
August 11, 2020
Public Version Number
4
DI Record Publish Date
February 12, 2017
Package DI Number
17290008325056
Quantity per Package
12
Contains DI Package
07290008325059
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box
| 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. | 4 |