Catalog Number

PMI50ML

Brand Name

PMI

Version/Model Number

PMI50ML

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KPE

Product Code Name

Container, I.V.

Public Device Record Key

bebedda3-bc1a-4680-b1b4-645e1ce764c0

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

May 01, 2018

Package DI Number

00812608021604

Quantity per Package

6

Contains DI Package

10812608021595

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case