Catalog Number

301-001-12110EA

Brand Name

Curaplex

Version/Model Number

301-001-12110EA

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BSY

Product Code Name

CATHETERS, SUCTION, TRACHEOBRONCHIAL

Public Device Record Key

d174ae2f-bf1e-495c-ab62-8762da24ea70

Public Version Date

April 20, 2020

Public Version Number

3

DI Record Publish Date

June 20, 2017

Package DI Number

00812574029512

Quantity per Package

50

Contains DI Package

00812574029505

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX