Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

NP-0450N

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)

-

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

02ab1a48-f129-4849-8ce0-7206a698fcf5

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

November 29, 2016

Package DI Number

50749756908196

Quantity per Package

10

Contains DI Package

00749756908191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case