Catalog Number

NIPJ 35150-H

Brand Name

NI-FLEX

Version/Model Number

NI-FLEX

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

KGZ

Product Code Name

Accessories, Catheter

Public Device Record Key

1c39f817-f14d-447a-8847-4b6111030221

Public Version Date

March 09, 2021

Public Version Number

1

DI Record Publish Date

March 01, 2021

Package DI Number

28033003344969

Quantity per Package

5

Contains DI Package

08033003344965

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-