Catalog Number

-

Brand Name

Axiom® Uni-Sump

Version/Model Number

111176

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K771048,K771048,K771048

Product Code

FEG

Product Code Name

Tube, Double Lumen For Intestinal Decompression And/Or Intubation

Public Device Record Key

6aa3c6b4-4d7b-46bd-9a90-c5f39ce3f0d2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

M6651111763

Quantity per Package

10

Contains DI Package

M6651111761

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case