Identity
- Trade Name
- Mini ONE® Balloon Button FDA UDI
- Generic Name
- Gastrostomy button FDA UDI
- Device Name
- 10FR x 2.7 cm Mini ONE® Balloon Button (Boxed Kit -I) Low Profile Feeding Device FDA UDI
- Model / Reference
- M1-5-1027-I FDA UDI
- Description
- 10FR x 2.7 cm Mini ONE® Balloon Button (Boxed Kit -I) Low Profile Feeding Device FDA UDI
Identifiers
- Catalog Number
- M1-5-1027-I FDA UDI
- Primary DI / UDI-DI
- 00842071120719 FDA UDI
- 510(k) Number
- 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
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 2.7 Centimeter FDA UDICatheter Gauge — 10 French FDA UDI
Category: Gastrostomy buttonEnteral feeding noninvasive-component set
Mini ONE® Balloon Button by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Enteral feeding noninvasive-component set.
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Cleared under the same submission
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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI 8eb694c3-9ab7-4d1c-acff-77092edb313d 37 fields · synced Jun 9, 2026