Catalog Number

-

Brand Name

Ameritus

Version/Model Number

KMI 805-ABG

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)

-

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

f5dcb1b6-d382-40b4-8d08-13cdd7e706a8

Public Version Date

November 19, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10817522013053

Quantity per Package

1

Contains DI Package

20817522013050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-