Catalog Number

-

Brand Name

ACIST Navvus® Catheter

Version/Model Number

014667

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"

-

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

K132474,K132474,K132474,K132474

Product Code

DXO

Product Code Name

Transducer, Pressure, Catheter Tip

Public Device Record Key

e2e0f12d-91ba-47eb-b1af-9177b9662fa6

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

20841716100004

Quantity per Package

5

Contains DI Package

10841716100007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner box