Dale ENFit ACE Connector - The Dale ENFit ACE Connector is a plastic - DALE MEDICAL PRODUCTS, INC.

Duns Number:001061233

Device Description: The Dale ENFit ACE Connector is a plastic universal connector that provides in-line feedin The Dale ENFit ACE Connector is a plastic universal connector that provides in-line feeding, suctioning, irrigation and medication while reducing the risk of potentially infectious splash back. The connector controls fluid flow into and out of most NG feeding tubes and other enteral tubes that use the ENFit connection system. The connector remains closed to the atmosphere, reducing the risk of cross contamination and eliminates mess and formula loss by maintaining a closed system (no disconnect). It has a simple ON/OFF handle and built in Needleless Syringe Port Seal which accepts most ENFit tip syringes. It is designed to physically prevent the administration of enteral formula into an I.V. line and is incompatible with luer connectors. The ENFit ACE Connector is DEHP free and not made with natural latex rubber.

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More Product Details

Catalog Number

485

Brand Name

Dale ENFit ACE Connector

Version/Model Number

485

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K082241,K082241

Product Code Details

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Device Record Status

Public Device Record Key

3f5e8482-7f6a-45ad-bf97-51efef6e5d61

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 04, 2017

Additional Identifiers

Package DI Number

H84104852

Quantity per Package

50

Contains DI Package

H84104851

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DALE MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 74
2 A medical device with a moderate to high risk that requires special controls. 2