Catalog Number

301-0318LTEZ-PED

Brand Name

Curaplex

Version/Model Number

301-0318LTEZ-PED

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 18, 2020

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

BYG

Product Code Name

MASK, OXYGEN

Public Device Record Key

8409fe08-0945-4281-857c-526b1b1cefb8

Public Version Date

January 14, 2021

Public Version Number

2

DI Record Publish Date

July 01, 2019

Package DI Number

00818834026192

Quantity per Package

30

Contains DI Package

00818834026185

Package Discontinue Date

December 18, 2020

Package Status

Not in Commercial Distribution

Package Type

BX