Identity
- Trade Name
- AMT Replacement Adapter EUDAMEDY-Port Feeding Adapter FDA UDI
- Generic Name
- Luer/non-ISO80369-standardized linear connector, single-use FDA UDI
- Device Name
- AMT Replacement Adapter EUDAMED15 FR Y-Port Replacement (Pouched), MDR FDA UDI
- Model / Reference
- E4-2015 EUDAMEDFDA UDI
- Description
- 15 FR Y-Port Replacement (Pouched), MDR FDA UDI
Identifiers
- Catalog Number
- E4-2015, 4-2015 FDA UDI
- Primary DI / UDI-DI
- 00842071133405 EUDAMEDFDA UDI
- Basic UDI-DI
- 08420711YPORTMM EUDAMED
- 510(k) Number
- K043027 FDA UDI
- FDA Product Code
- KNT FDA UDI
- EMDN Code
- G020299 GASTROINTESTINAL FEEDING/ASPIRATION TUBES - OTHER EUDAMED
- GMDN Term
- Luer/non-ISO80369-standardized linear connector, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — 15 French FDA UDI
AMT Replacement Adapter by Applied Medical Technology, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08420711YPORTMM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
- EUDAMED SRN
- US-MF-000041414
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 8593d649-8c23-4627-9cc1-708cfa4fd643 61 fields · synced Jul 31, 2026
- FDA UDI 3d0bea9d-dedd-4f76-bab3-2b2fff695b54 37 fields · synced May 30, 2026