Catalog Number

NIO-I

Brand Name

NIO NEXT GENERATION IO

Version/Model Number

1

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

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

516961e5-1e3d-4953-b37b-9f64a50dcc71

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 26, 2021

Package DI Number

10850026832027

Quantity per Package

12

Contains DI Package

00850026832020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX