Catalog Number

HS-002

Brand Name

Nimbus

Version/Model Number

HS-002

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

K140783,K140783,K140783

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

4ce4b824-a5aa-4196-980b-c5e4d1087963

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 31, 2017

Package DI Number

40817170020046

Quantity per Package

12

Contains DI Package

30817170020049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case