Catalog Number

NIO-A

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

K182770,K182770

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

3d47afaa-dcbd-4930-835f-d7af1d386032

Public Version Date

February 17, 2021

Public Version Number

1

DI Record Publish Date

February 09, 2021

Package DI Number

10850026832034

Quantity per Package

12

Contains DI Package

00850026832037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX