Catalog Number

20-02-0151

Brand Name

Allied Healthcare Products Inc.

Version/Model Number

13305

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"

-

For Single-Use

Yes

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

daa6f2ae-e81a-4a8d-a60a-01aed03e8659

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

40026072002467

Quantity per Package

12

Contains DI Package

00026072002469

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case