Identity
- Trade Name
- AMT Mini™ Balloon Button FDA UDI
- Generic Name
- Gastrostomy button FDA UDI
- Device Name
- 16FR x 2.7 cm Mini Balloon Button with Patient Care Kit FDA UDI
- Model / Reference
- 5-1627 FDA UDI
- Description
- 16FR x 2.7 cm Mini Balloon Button with Patient Care Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842071110321 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
Dimensions & Sizes
- Size
- Length — 2.7 Centimeter FDA UDICatheter Gauge — 16 French FDA UDI
Category: Gastrostomy button
AMT Mini™ Balloon Button by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
Sources (1)
- FDA UDI 47b51cf4-10b2-4715-8cf2-d4a359420fee 36 fields · synced Jun 9, 2026