Duns Number:514619238
Device Description: The NIO-Infant (NIO-I) is an intraosseous device intended to provide vascular access in th The NIO-Infant (NIO-I) is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.
Catalog Number
-
Brand Name
NIO
Version/Model Number
NIO-I
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
K190538,K190538
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
478a1c39-98fb-4570-b555-546aa039a695
Public Version Date
November 19, 2019
Public Version Number
1
DI Record Publish Date
November 11, 2019
Package DI Number
17290008325063
Quantity per Package
12
Contains DI Package
07290008325066
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 |