Enteral Feeding - Enteral Syringe 60mL, Bonded Slip Tip Connector - MEDELA, INC.

Duns Number:052002029

Device Description: Enteral Syringe 60mL, Bonded Slip Tip Connector

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More Product Details

Catalog Number

-

Brand Name

Enteral Feeding

Version/Model Number

INT60

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

K894206,K894206

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

9a4f142d-0c90-428b-9b77-d2e25b45b900

Public Version Date

October 29, 2021

Public Version Number

8

DI Record Publish Date

December 20, 2017

Additional Identifiers

Package DI Number

20020451331366

Quantity per Package

50

Contains DI Package

00020451331362

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