Enteral Feeding - Enteral Extension Set, 70", Low Volume Minibore, - MEDELA, INC.

Duns Number:052002029

Device Description: Enteral Extension Set, 70", Low Volume Minibore, Approx. Priming Vol. 1.50 mL, TwistLok

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More Product Details

Catalog Number

-

Brand Name

Enteral Feeding

Version/Model Number

TL-070-18

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

K895367,K895367

Product Code Details

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

474aedf5-50ae-4812-ab6d-88ba90bdba83

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

20020451101167

Quantity per Package

100

Contains DI Package

00020451101163

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