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MiniONE Balloon Button

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref M1-5-1408

by Applied Medical Technology, Inc.

Identity

Trade Name
MiniONE® Balloon Button - Low Profile Gastrostomy Feeding Tube EUDAMED
MiniONE Balloon Button FDA UDI
Generic Name
Gastrostomy button FDA UDI
Device Name
Low Profile Balloon Button EUDAMED
14FR x 0.8cm MiniONE Balloon Button - Low Profile Feeding Device, MDR FDA UDI
Model / Reference
M1-5-1408 EUDAMEDFDA UDI
Description
14FR x 0.8cm MiniONE Balloon Button - Low Profile Feeding Device, MDR FDA UDI

Identifiers

Catalog Number
M1-5-1408 FDA UDI
Primary DI / UDI-DI
00842071140724 EUDAMEDFDA UDI
Basic UDI-DI
08420711BALLOONBUTTON7U EUDAMED
510(k) Number
K161413 FDA UDI
K945618 FDA UDI
FDA Product Code
KNT FDA UDI
EMDN Code
G02020201 GASTROSTOMY, TUBES AND SETS EUDAMED
GMDN Term
Gastrostomy button FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Market of Registration
Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 14 French FDA UDI
Length — 0.8 Centimeter FDA UDI

Category: Gastrostomy button

MiniONE Balloon Button by Applied Medical Technology, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Gastrostomy button.

Cleared under the same submission

K161413 also covers:

K945618 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied Medical Technology, Inc.

Sources (2)

  • FDA UDI 2763e9b4-b0bb-4e5b-bf5f-11c18d1efaeb 37 fields · synced Aug 1, 2026
  • EUDAMED 0de3f988-f526-443a-bfc8-e0ff36a012f3 61 fields · synced Aug 1, 2026