Catalog Number

HS-004

Brand Name

Nimbus

Version/Model Number

HS-004

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

07e71d18-6eea-4e2d-ae0e-2d2cf3b329bb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 15, 2016

Package DI Number

40817170020039

Quantity per Package

12

Contains DI Package

30817170020032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case