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AMT Y-Port Accessory

FDA UDI

Class II (US FDA UDI)

by Applied Medical Technology, Inc.

Identity

Trade Name
AMT Y-Port Accessory FDA UDI
Generic Name
Enteral feeding kit, adult/paediatric, sterile FDA UDI
Device Name
Single ENFit Y-Port Accessory (Single Female Enfit to Male Enfit and Bolus Port) FDA UDI
Model / Reference
E4-0005 FDA UDI
Description
Single ENFit Y-Port Accessory (Single Female Enfit to Male Enfit and Bolus Port) FDA UDI

Identifiers

Catalog Number
E4-0005, 4-0005 FDA UDI
Primary DI / UDI-DI
00842071113612 FDA UDI
510(k) Number
K142989 FDA UDI
K971757 FDA UDI
FDA Product Code
PIF FDA UDI
KNT FDA UDI
GMDN Term
Enteral feeding kit, adult/paediatric, sterile 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

Category: Enteral feeding kit, adult/paediatric, sterile

AMT Y-Port Accessory by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Enteral feeding kit, adult/paediatric, sterile.

Cleared under the same submission

K142989 also covers:

K971757 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied Medical Technology, Inc.

Sources (1)

  • FDA UDI 4c6f14b5-e0c8-4ca2-8f41-66e1d5329ac7 36 fields · synced Jun 9, 2026