FDA.reportPublic FDA data

Dale ENFit ACE Connector

Primary DI
00817612020261
Brand
Dale ENFit ACE Connector
Company
Dale Medical Products, Inc.
Model
485
Catalog number
485
Device description
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.
Published
2019-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
00817612020278PackageGS150In Commercial Distribution
H84104851PreviousHIBCC0
00817612020261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817612020278008176120202788176120202780817612020278
00817612020261008176120202618176120202610817612020261

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253012354KangarooCardinal Health 200, LLCKNT2025-07-11
00842071136642MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136659MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136666MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136673MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136680MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136697MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136703MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136710MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071132163MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132170MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132187MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132194MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071121105MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121112MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121129MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121136MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121143MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121150MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121167MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121174MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121181MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121198MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121204MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121211MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121228MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121235MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121242MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121259MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121266MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11