Enteral Feeding - 3mL Non-Sterile Enteral/Oral Syringe with ENFit - MEDELA, INC.

Duns Number:052002029

Device Description: 3mL Non-Sterile Enteral/Oral Syringe with ENFit Low Dose Tip

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More Product Details

Catalog Number

-

Brand Name

Enteral Feeding

Version/Model Number

101034138

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"

Yes

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

K162188,K162188,K162188,K162188

Product Code Details

Product Code

PNR

Product Code Name

Enteral Syringes With Enteral Specific Connectors

Device Record Status

Public Device Record Key

7784b846-ca8b-4b7a-b663-ccf2a36ba9cd

Public Version Date

October 29, 2021

Public Version Number

7

DI Record Publish Date

July 28, 2017

Additional Identifiers

Package DI Number

30020451330946

Quantity per Package

6

Contains DI Package

20020451330949

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