Catalog Number

-

Brand Name

Roscoe Medical

Version/Model Number

ASP-ROS

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

-

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

K080005,K080005

Product Code

JCX

Product Code Name

Apparatus, Suction, Ward Use, Portable, Ac-Powered

Public Device Record Key

df174a96-be0c-43b8-bbd7-ca2b517d2eb2

Public Version Date

April 13, 2021

Public Version Number

1

DI Record Publish Date

April 05, 2021

Package DI Number

30092237622811

Quantity per Package

2

Contains DI Package

00092237622810

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case