Enteral Feeding - Enteral Syringe 3 mL, Bonded TwistLok Connector - MEDELA, INC.

Duns Number:052002029

Device Description: Enteral Syringe 3 mL, Bonded TwistLok Connector

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More Product Details

Catalog Number

-

Brand Name

Enteral Feeding

Version/Model Number

TLINT03

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

K894206,K894206

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

99dc8ef5-f347-4502-9377-82ea3d1532a9

Public Version Date

October 29, 2021

Public Version Number

7

DI Record Publish Date

December 20, 2017

Additional Identifiers

Package DI Number

20020451331571

Quantity per Package

100

Contains DI Package

00020451331577

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