Catalog Number

301-195EA

Brand Name

Curaplex

Version/Model Number

301-195EA

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BYG

Product Code Name

MASK, OXYGEN

Public Device Record Key

c50c51ad-9950-4849-b237-2e540124cb34

Public Version Date

July 12, 2019

Public Version Number

2

DI Record Publish Date

February 10, 2019

Package DI Number

00818834022095

Quantity per Package

10

Contains DI Package

00818834021555

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS