Catalog Number

PIB500/A

Brand Name

Merit Medical®

Version/Model Number

00884450006832

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KZD

Product Code Name

INFUSOR, PRESSURE, FOR I.V. BAGS

Public Device Record Key

b7d51019-1947-4cd5-8b75-893d5ca4870c

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

February 16, 2018

Package DI Number

10884450006839

Quantity per Package

12

Contains DI Package

00884450006832

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-