Enteral Feeding - Polyurethane Enteral Feeding Tube, 16", 8FR, - MEDELA, INC.

Duns Number:052002029

Device Description: Polyurethane Enteral Feeding Tube, 16", 8FR, Approx. Priming Vol. 0.80 mL, TwistLok

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More Product Details

Catalog Number

-

Brand Name

Enteral Feeding

Version/Model Number

ENPU1680

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K080328,K080328

Product Code Details

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Device Record Status

Public Device Record Key

d1607056-f0e0-4c79-8d74-ec3f3eebbbc3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 20, 2017

Additional Identifiers

Package DI Number

20020451331113

Quantity per Package

10

Contains DI Package

00020451331119

Package Discontinue Date

-

Package Status

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