Catalog Number

30-4069A

Brand Name

DeRoyal

Version/Model Number

30-4069A

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

e234cc24-21bd-4d88-932a-abdb44f0e118

Public Version Date

June 30, 2021

Public Version Number

1

DI Record Publish Date

June 22, 2021

Package DI Number

50749756732951

Quantity per Package

504

Contains DI Package

00749756732956

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case