Catalog Number

28-3133C

Brand Name

DeRoyal

Version/Model Number

28-3133C

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

BYY

Product Code Name

TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Public Device Record Key

5724e81f-2e30-43e2-890c-29619c9c2539

Public Version Date

August 31, 2021

Public Version Number

1

DI Record Publish Date

August 23, 2021

Package DI Number

50749756976898

Quantity per Package

25

Contains DI Package

00749756976893

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case