Catalog Number

-

Brand Name

Protection Products Inc.

Version/Model Number

ERT0005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 10, 2019

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MAC

Product Code Name

Decontamination kit

Public Device Record Key

f088a880-b5dd-4f01-9f14-e7b766884952

Public Version Date

July 11, 2019

Public Version Number

2

DI Record Publish Date

November 19, 2018

Package DI Number

20809160219000

Quantity per Package

16

Contains DI Package

10809160219003

Package Discontinue Date

July 10, 2019

Package Status

Not in Commercial Distribution

Package Type

-