Catalog Number

-

Brand Name

Roscoe Medical

Version/Model Number

50004

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

-

Product Code

JCX

Product Code Name

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

Public Device Record Key

b16584d6-1853-4cfb-bd6f-cc241d5d2491

Public Version Date

May 23, 2019

Public Version Number

3

DI Record Publish Date

October 07, 2016

Package DI Number

20092237603370

Quantity per Package

2

Contains DI Package

00092237603376

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA