Catalog Number

901501

Brand Name

Enteroclysis Catheter 13Fx155cm

Version/Model Number

901501

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

K911349,K911349

Product Code

EZK

Product Code Name

Catheter, Retention Type

Public Device Record Key

953b5dca-38fa-4aa6-8c9c-0c75d6d82c8e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

50815112021097

Quantity per Package

24

Contains DI Package

30815112021093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box