FDA UDI
In Commercial Distribution
🇺🇸 United States
Y-Port Feeding Adapter
DI: 00842071131685
·
Model: E4-2014
·
APPLIED MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Y-Port Feeding Adapter
- Primary DI
- 00842071131685
- Version / Model
- E4-2014
- Catalog Number
- E4-2014, 4-2014
- Company Name
- APPLIED MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 038101861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-05
- Public Version
- 2
- Public Version Date
- 2023-08-07
- Public Version Status
- Update
- Public Device Record Key
- 12821aa3-a1b8-46c7-b3fc-47ea658128d8
Device Description
14FR Y-Port Replacement (Pouched)
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| 64467 | Luer/non-ISO80369-standardized linear connector, single-use | A small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, bayonet, collet, conical, threaded or non-Luer-slip) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing or an external puncturing component. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00842071131586 | GS1 | Box (4-2014) | 10 | In Commercial Distribution | |
| Primary | 00842071131685 | GS1 |
Customer Contacts
- Phone
- (440) 717-4000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K043027 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 14 | French |