Identity
- Trade Name
- MiniONE® Non-Balloon Button - Low Profile Gastrostromy Feeding Tube EUDAMEDMiniONE Non-Balloon Button FDA UDI
- Generic Name
- Gastrostomy button FDA UDI
- Device Name
- Low Profile Non-Balloon Button EUDAMED14FR x 1.2 cm MiniONE Non-Balloon Button (ENFit), MDR FDA UDI
- Model / Reference
- M1-1-1412-I EUDAMEDFDA UDI
- Description
- 14FR x 1.2 cm MiniONE Non-Balloon Button (ENFit), MDR FDA UDI
Identifiers
- Catalog Number
- M1-1-1412-I FDA UDI
- Primary DI / UDI-DI
- 00842071143336 EUDAMEDFDA UDI
- Basic UDI-DI
- 08420711NBBUTTONQU EUDAMED
- 510(k) Number
- K170319 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 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 Safe FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 14 French FDA UDILength — 1.2 Centimeter FDA UDI
Category: Gastrostomy button
MiniONE Non-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.
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- CORFLO cuBBy LPGD — Corpak Medsystems · Class II
- CORFLO cuBBy LPGD — Corpak Medsystems · Class II
- AVANOS — Avanos Medical, Inc. · Class II
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- Halyard — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
Cleared under the same submission
K170319 also covers:
- MiniONE Non-Balloon Button — Applied Medical Technology, Inc.
- MiniONE Non-Balloon Button — Applied Medical Technology, Inc.
- MiniONE Non-Balloon Button — Applied Medical Technology, Inc.
- MiniONE Non-Balloon Button — Applied Medical Technology, Inc.
- MiniONE Non-Balloon Button — Applied Medical Technology, Inc.
- MiniONE Non-Balloon Button — Applied Medical Technology, Inc.
- MiniONE Non-Balloon Button — Applied Medical Technology, Inc.
- MiniONE Non-Balloon Button — Applied Medical Technology, Inc.
- MiniONE Non-Balloon Button — Applied Medical Technology, Inc.
- MiniONE Non-Balloon Button — Applied Medical Technology, Inc.
- MiniONE Non-Balloon Button — Applied Medical Technology, Inc.
- MiniONE Non-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 |
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Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
Sources (2)
- FDA UDI 97b1cbd1-9001-4916-9b39-b2e6b6a01e49 37 fields · synced Sep 17, 2026
- EUDAMED ec511d65-d7cf-43a3-8cee-4634312fc48f 61 fields · synced Sep 17, 2026