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MiniONE Balloon Button

FDA UDI

Class II (US FDA UDI)

by Applied Medical Technology, Inc.

Identity

Trade Name
MiniONE Balloon Button FDA UDI
Generic Name
Gastrostomy button FDA UDI
Device Name
10FR x 1.0cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR FDA UDI
Model / Reference
M1-5-1010-I FDA UDI
Description
10FR x 1.0cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR FDA UDI

Identifiers

Catalog Number
M1-5-1010-I FDA UDI
Primary DI / UDI-DI
00842071145095 FDA UDI
510(k) Number
K161413 FDA UDI
K945618 FDA UDI
FDA Product Code
KNT FDA UDI
GMDN Term
Gastrostomy button 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

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
Length — 1.0 Centimeter FDA UDI
Catheter Gauge — 10 French FDA UDI

Category: Gastrostomy button

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

Similar devices

Also classified as Gastrostomy button.

Cleared under the same submission

K161413 also covers:

K945618 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 1941e08e-4f18-4b0b-a9f0-fe832681e1be 37 fields · synced Jun 9, 2026