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AMT MiniONE Extension Set

FDA UDI

Class II (US FDA UDI)

by Applied Medical Technology, Inc.

Identity

Trade Name
AMT MiniONE Extension Set FDA UDI
Generic Name
Enteral tube extension, single-use FDA UDI
Device Name
12" MiniONE Bolus Feeding Set with ENFit® and Cap (Box 10), MDR FDA UDI
Model / Reference
8-1211-ISOSAF FDA UDI
Description
12" MiniONE Bolus Feeding Set with ENFit® and Cap (Box 10), MDR FDA UDI

Identifiers

Catalog Number
8-1211-ISOSAF FDA UDI
Primary DI / UDI-DI
00842071132392 FDA UDI
510(k) Number
K110804 FDA UDI
K123716 FDA UDI
K142989 FDA UDI
K971757 FDA UDI
FDA Product Code
KNT FDA UDI
PIF FDA UDI
GMDN Term
Enteral tube extension, 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
Length — 12 Inch FDA UDI

Category: Enteral tube extension, single-use

AMT MiniONE Extension Set by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Enteral tube extension, single-use.

Cleared under the same submission

K110804 also covers:

K123716 also covers:

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 b856dcec-3bb3-405b-86c6-67a2c5ff1295 37 fields · synced Jun 9, 2026