Catalog Number

NIO-P

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

K191258,K191258

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

8cabde6c-4e77-48ab-81d2-ea862fa2d404

Public Version Date

February 17, 2021

Public Version Number

1

DI Record Publish Date

February 09, 2021

Package DI Number

10850026832003

Quantity per Package

12

Contains DI Package

00850026832006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box