Enteral Feeding - Bifurcated Enteral Extension Set, 60", Low Volume - MEDELA, INC.

Duns Number:052002029

Device Description: Bifurcated Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.70 mL, Bifurcated Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.70 mL, ENFit

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Enteral Feeding

Version/Model Number

ENF06019

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 14, 2018

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K895367,K895367

Product Code Details

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

975c0b6c-197c-4550-9fa3-ea84f7c75d6e

Public Version Date

August 16, 2018

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

20020451100214

Quantity per Package

100

Contains DI Package

00020451100210

Package Discontinue Date

August 14, 2018

Package Status

Not in Commercial Distribution

Package Type

-

"MEDELA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 244