Catalog Number

0034630

Brand Name

Closed Wound Suction

Version/Model Number

0034630

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)

Yes

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

GCY

Product Code Name

APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Public Device Record Key

33f89f9e-68a2-4437-81a3-37ec59ce4556

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

September 22, 2020

Package DI Number

20801741049143

Quantity per Package

2

Contains DI Package

10801741049146

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA