Catalog Number

-

Brand Name

Curaplex

Version/Model Number

301-P3001EA

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

CAT

Product Code Name

CANNULA, NASAL, OXYGEN

Public Device Record Key

1869c1d7-71b3-4914-a88d-0693eccd928f

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

December 14, 2016

Package DI Number

00812574025828

Quantity per Package

25

Contains DI Package

00812574025835

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-