Identity
- Trade Name
- AVANOS FDA UDI
- Generic Name
- Gastrostomy button FDA UDI
- Device Name
- MIC-KEY* Gastrostomy Feeding Tube Kit, SECUR-LOK* Extension Sets FDA UDI
- Model / Reference
- 94893 FDA UDI
- Description
- MIC-KEY* Gastrostomy Feeding Tube Kit, SECUR-LOK* Extension Sets FDA UDI
Identifiers
- Catalog Number
- 0120-18-5.0 FDA UDI
- Primary DI / UDI-DI
- 00350770948935 FDA UDI
- 510(k) Number
- K043114 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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 — 18 French FDA UDI
Category: Gastrostomy button
Avanos by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrostomy button.
- Mini ONE® Balloon Button — Applied Medical Technology, Inc. · Class II
- MiniONE Balloon Button — Applied Medical Technology, Inc. · Class II
- MiniONE Balloon Button — Applied Medical Technology, Inc. · Class II
- MiniONE Non-Balloon Button — Applied Medical Technology, Inc. · Class II
- Mini ONE® Balloon Button — Applied Medical Technology, Inc. · Class II
- AMT Mini™ Balloon Button — Applied Medical Technology, Inc. · Class II
- Mini ONE® Non-Balloon Button — Applied Medical Technology, Inc. · Class II
- CORFLO cuBBy LPGD — Corpak Medsystems · Class II
Cleared under the same submission
K043114 also covers:
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, 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
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 6697f12b-71d8-437b-9702-1d94f62c9d8e 37 fields · synced Jun 9, 2026