Identity
- Trade Name
- MiniONE® Balloon Button - Low Profile Gastrostomy Feeding Tube EUDAMEDMiniONE Balloon Button FDA UDI
- Generic Name
- Gastrostomy button FDA UDI
- Device Name
- Low Profile Balloon Button EUDAMED12FR x 2.0 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR FDA UDI
- Model / Reference
- SM1-5-1220 EUDAMEDFDA UDI
- Description
- 12FR x 2.0 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR FDA UDI
Identifiers
- Catalog Number
- SM1-5-1220 FDA UDI
- Primary DI / UDI-DI
- 00842071142360 EUDAMEDFDA UDI
- Basic UDI-DI
- 08420711BALLOONBUTTON7U EUDAMED
- 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 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
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 12 French FDA UDILength — 2.0 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
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Cleared under the same submission
K161413 also covers:
- MINI Balloon Button — Applied Medical Technology, Inc.
- MINI Balloon Button — Applied Medical Technology, Inc.
- Mini ONE® Balloon Button — Applied Medical Technology, Inc.
- Mini ONE® Balloon Button — Applied Medical Technology, Inc.
- Mini ONE® Balloon Button — Applied Medical Technology, Inc.
- Mini ONE® Balloon Button — Applied Medical Technology, Inc.
- Mini ONE® Balloon Button — Applied Medical Technology, Inc.
- Mini ONE® Balloon Button — Applied Medical Technology, Inc.
- Mini ONE® Balloon Button — Applied Medical Technology, Inc.
- MiniONE Balloon Button — Applied Medical Technology, Inc.
- MiniONE Balloon Button — Applied Medical Technology, Inc.
- MiniONE Balloon Button — Applied Medical Technology, Inc.
K945618 also covers:
- AMT Mini Extension Set — Applied Medical Technology, Inc.
- AMT Mini™ Balloon Button — Applied Medical Technology, Inc.
- AMT Mini™ Balloon Button — Applied Medical Technology, Inc.
- AMT Mini™ Balloon Button — Applied Medical Technology, Inc.
- AMT Mini™ Balloon Button — Applied Medical Technology, Inc.
- AMT Mini™ Balloon Button — Applied Medical Technology, Inc.
- AMT Mini™ Balloon Button — Applied Medical Technology, Inc.
- AMT Mini™ Balloon Button — Applied Medical Technology, Inc.
- AMT Mini™ Balloon Button — Applied Medical Technology, Inc.
- AMT Mini™ Balloon Button — Applied Medical Technology, Inc.
- AMT Mini™ Balloon Button — Applied Medical Technology, Inc.
- AMT Mini™ Balloon Button — Applied Medical Technology, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
Sources (2)
- FDA UDI a371197c-bdeb-48f6-9312-4dbc599f0a12 37 fields · synced Sep 17, 2026
- EUDAMED a5bd427d-a943-4e06-aedb-14a8cb8e17a0 61 fields · synced Sep 17, 2026