Catalog Number

HD-395-0500EU

Brand Name

DeRoyal

Version/Model Number

HD-395-0500EU

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

7b044eb5-41b7-4343-9cab-7d40ba9be541

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

June 23, 2021

Package DI Number

50749756838127

Quantity per Package

390

Contains DI Package

00749756838122

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case