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

Duns Number:001061233

Device Description: The Dale ACE Connector is a plastic universal connector that provides in-line feeding, suc The Dale ACE Connector is a plastic universal connector that provides in-line feeding, suctioning, irrigation and medication delivery 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. 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 catheter tip 60 ml syringes. It is designed to physically prevent the administration of enteral formula into an I.V. line and is incompatible with luer connectors. The ACE Connector is DEHP free and not made with natural rubber latex.

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More Product Details

Catalog Number

475

Brand Name

Dale ACE Connector

Version/Model Number

475

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

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

8444c5fa-61e8-4597-82bd-679e3688647b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 02, 2016

Additional Identifiers

Package DI Number

H84104752

Quantity per Package

50

Contains DI Package

H84104751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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