Catalog Number

-

Brand Name

ACIST Navvus®II Catheter

Version/Model Number

016675

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

K190473,K190473,K190473

Product Code

OBI

Product Code Name

Catheter, Pressure Monitoring, Cardiac

Public Device Record Key

c00d8396-fdb7-4d8e-b408-4c1817c0fa2e

Public Version Date

May 20, 2020

Public Version Number

1

DI Record Publish Date

May 12, 2020

Package DI Number

20841716102480

Quantity per Package

5

Contains DI Package

10841716102483

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box