Catalog Number

HD-395-6000EU

Brand Name

DeRoyal

Version/Model Number

HD-395-6000EU

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FNY

Product Code Name

BASIN, EMESIS

Public Device Record Key

25a2ad6f-d781-4bea-9968-d7a1c0aaa001

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

June 23, 2021

Package DI Number

50749756837724

Quantity per Package

60

Contains DI Package

00749756837729

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case