Catalog Number

-

Brand Name

Unimax

Version/Model Number

FSC614460

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

BSY

Product Code Name

Catheters, Suction, Tracheobronchial

Public Device Record Key

042aec59-2e46-4e35-a349-babb0e42a608

Public Version Date

May 11, 2022

Public Version Number

1

DI Record Publish Date

May 03, 2022

Package DI Number

14714127868568

Quantity per Package

25

Contains DI Package

04714127868561

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box