Catalog Number

SAMPC0543

Brand Name

Medline Industries, Inc.

Version/Model Number

SAMPC0543

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 21, 2021

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

K052865

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Public Device Record Key

efeeab3c-8d3e-4eb5-be58-150f761dd216

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

March 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-