Catalog Number

8888266122

Brand Name

Salem Sump

Version/Model Number

8888266122

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

FEG

Product Code Name

TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Public Device Record Key

069946b7-d621-4b54-ba28-7992143c94ce

Public Version Date

October 12, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521004693

Quantity per Package

50

Contains DI Package

10884521004696

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE