Catalog Number

8888265132

Brand Name

Salem Sump

Version/Model Number

8888265132

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

K830710,K830710

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

d7c3beba-c627-4870-985e-2883414f3692

Public Version Date

February 15, 2019

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

20884521020099

Quantity per Package

10

Contains DI Package

10884521020092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE