Catalog Number

-

Brand Name

Medela

Version/Model Number

ENSI9080

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"

Yes

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

K090559,K090559,K090559

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

385c984f-027b-486b-b7c5-66419e5c11c9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 16, 2017

Package DI Number

10859950007440

Quantity per Package

10

Contains DI Package

00859950007443

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton