FDA.reportPublic FDA data

Dale ACE Connector

Primary DI
H84104751
Brand
Dale ACE Connector
Company
Dale Medical Products, Inc.
Model
475
Catalog number
475
Device description
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.
Published
2016-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082241000THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751Dale Medical Products, Inc.2008-10-30KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817612020254PackageGS150In Commercial Distribution
H84104752PackageHIBCC50In Commercial Distribution
H84104751PreviousHIBCC0
00817612020247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817612020254008176120202548176120202540817612020254
00817612020247008176120202478176120202470817612020247

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding kit, adult/paediatric, sterileA collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001061233
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H84101501Dale Foley Catheter Holder1501502018-08-30
H84103161Dale Foley Catheter Holder3163162018-08-30
H84103301Dale Foley Catheter Holder3303302018-08-30
H84104901Dale Urodynamic Tube Holder4904902018-08-30
00817612020001Dale General Purpose Securement Device9529522018-09-10
00817612020025Dale Catheter Securement Device8538532018-09-10
00817612020124Dale Catheter Securement Device8508502018-09-10
00817612020148Dale Catheter Securement Device8518512018-09-10
00817612020162Dale Catheter Securement Device8528522018-09-10
00817612020186Dale Catheter Securement Device8548542018-09-10
00817612020209Dale General Purpose Securement Device9509502018-09-10
00817612020223Dale General Purpose Securement Device9519512018-09-10
00817612020902Dale Catheter Securement Device8498492018-09-10
00817612020926Dale Catheter Securement Device8488482018-10-10
00817612021107Dale IV Line Manager6306302025-08-11
00817612020544Dale Foley Catheter Holder1501502019-03-18
00817612020568Dale Foley Catheter Holder3163162019-03-18
00817612020582Dale Foley Catheter Holder3303302019-03-18
00817612021121Dale Airway Holder2602602026-03-11
00817612021114Dale IV Line Manager6306302025-08-11

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