Catalog Number

-

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

Labeling does not contain MRI Safety Information

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KMK

Product Code Name

Device, Intravascular Catheter Securement

Public Device Record Key

9a8916bc-cd49-4c80-bc7a-3688efaaf097

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

March 03, 2021

Package DI Number

10850026832102

Quantity per Package

12

Contains DI Package

00850026832105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX