Catalog Number

30-4067

Brand Name

DeRoyal

Version/Model Number

30-4067

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

-

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

KDQ

Product Code Name

BOTTLE, COLLECTION, VACUUM

Public Device Record Key

1f739eec-c45d-4d4c-be5e-94b879ebd9a1

Public Version Date

August 10, 2021

Public Version Number

2

DI Record Publish Date

June 22, 2021

Package DI Number

50749756732937

Quantity per Package

1728

Contains DI Package

00749756732932

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case