Dale ENFit ACE Connector
Basic Information
- Brand Name
- Dale ENFit ACE Connector
- Primary DI
- 00817612020261
- Version / Model
- 485
- Catalog Number
- 485
- Company Name
- DALE MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 001061233
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-29
- Public Version
- 1
- Public Version Date
- 2019-06-06
- Public Version Status
- New
- Public Device Record Key
- a3857af7-c4de-49aa-b454-8ee36c83504e
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11677 | Enteral feeding kit, adult/paediatric, sterile | A 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | H84104851 | HIBCC | ||||
| Package | 00817612020278 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 00817612020261 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082241 | 000 |