Identity
- Trade Name
- Y-Port Feeding Adapter FDA UDI
- Generic Name
- Luer/non-ISO80369-standardized linear connector, single-use FDA UDI
- Device Name
- 20 FR Y-Port Replacement (Pouched) FDA UDI
- Model / Reference
- E4-2020 FDA UDI
- Description
- 20 FR Y-Port Replacement (Pouched) FDA UDI
Identifiers
- Catalog Number
- E4-2020, 4-2020 FDA UDI
- Primary DI / UDI-DI
- 00842071131722 FDA UDI
- 510(k) Number
- K043027 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Luer/non-ISO80369-standardized linear connector, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 20 French FDA UDI
Category: Luer/non-ISO80369-standardized linear connector, single-use
Y-Port Feeding Adapter by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Luer/non-ISO80369-standardized linear connector, single-use.
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- Cook — COOK INCORPORATED · Class I
- CONNECTOR, REDUCER 3/16" X 1/4" W/LUER NO CAP — NOVOSCI CORP. · Class II
Cleared under the same submission
K043027 also covers:
- AMT Capsule Dome G-Tube — Applied Medical Technology, Inc.
- AMT Capsule Dome G-Tube — Applied Medical Technology, Inc.
- AMT Capsule Dome G-Tube — Applied Medical Technology, Inc.
- AMT Capsule Dome G-Tube — Applied Medical Technology, Inc.
- AMT Capsule Dome G-Tube — Applied Medical Technology, Inc.
- AMT Capsule Dome G-Tube — Applied Medical Technology, Inc.
- AMT Capsule Dome G-Tube — Applied Medical Technology, Inc.
- AMT Capsule Dome G-Tube — Applied Medical Technology, Inc.
- AMT Capsule Dome G-Tube — Applied Medical Technology, Inc.
- Capsule Dome G-Tube — Applied Medical Technology, Inc.
- Capsule Dome G-Tube — Applied Medical Technology, Inc.
- Capsule Dome G-Tube — Applied Medical Technology, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
Sources (1)
- FDA UDI a789da7c-ccd4-447c-b2f4-cab70cda8eb5 37 fields · synced Jun 9, 2026