Halyard

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name: Halyard FDA UDI
Generic Name: Gastrostomy button FDA UDI
Device Name: MIC-KEY* SF Gastrostomy Feeding Tube, Extension Sets with ENFit® Connectors FDA UDI
Model / Reference: 42906 FDA UDI
Description: MIC-KEY* SF Gastrostomy Feeding Tube, Extension Sets with ENFit® Connectors FDA UDI

Identifiers

Catalog Number: 7140-18-1.2 FDA UDI
Primary DI / UDI-DI: 10680651429060 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

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Gastrostomy button

Halyard by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Avanos Medical, Inc.

Sources (1)

FDA UDI 69238541-5257-4a3b-85fa-a829484625d0 35 fields · synced Jun 9, 2026