Duns Number:514619238
Device Description: The Pediatric NIO device is indicated to provide intraosseous access in the proximal tibia The Pediatric NIO device is indicated to provide intraosseous access in the proximal tibia as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age.
Catalog Number
-
Brand Name
NIO
Version/Model Number
NIO-P
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
K160805,K160805
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
f969fabe-48c8-4cf8-a9fc-75850e7a17d2
Public Version Date
August 11, 2020
Public Version Number
4
DI Record Publish Date
February 12, 2017
Package DI Number
17290008325025
Quantity per Package
12
Contains DI Package
07290008325028
Package Discontinue Date
-
Package Status
In Commercial Distribution
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. | 4 |