Catalog Number

91002

Brand Name

PM Plus High

Version/Model Number

91002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

LAS

Product Code Name

Drug Specific Control Materials

Public Device Record Key

2fc77a1d-42a7-42a5-87a9-7a8ef758b51f

Public Version Date

April 23, 2020

Public Version Number

1

DI Record Publish Date

April 15, 2020

Package DI Number

B800910025

Quantity per Package

5

Contains DI Package

B800910020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box