Halyard

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name: Halyard FDA UDI
Generic Name: Gastrostomy tube FDA UDI
Device Name: MIC-KEY* Threaded Extension Set, SECUR-LOK* Right Angle Connector and Clamp FDA UDI
Model / Reference: 94944 FDA UDI
Description: MIC-KEY* Threaded Extension Set, SECUR-LOK* Right Angle Connector and Clamp FDA UDI

Identifiers

Catalog Number: 0126-24 FDA UDI
Primary DI / UDI-DI: 20680651949442 FDA UDI
510(k) Number: K982894 FDA UDI
FDA Product Code: KNT FDA UDI
GMDN Term: Gastrostomy tube 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

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

Category: Gastrostomy tube

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

Similar devices

Also classified as Gastrostomy tube.

Balloon G-Tube — Applied Medical Technology, Inc. · Class II
Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection — Xeridiem Medical Devices · Class II
AMT Balloon G-Tube — Applied Medical Technology, Inc. · Class II
Low-Profile Gastrostomy Replacement Tube (G. Button) Kit — Sky Medical a.s. · Class IIb
Kangaroo — Cardinalhealth · Class II
Gastrostomy Tube — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
EndoVive™ Low Profile Replacement Button — Boston Scientific · Class II
AMT Capsule Dome G-Tube — Applied Medical Technology, Inc. · Class II

Cleared under the same submission

K982894 also covers:

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 1104d66a-82a3-4563-8370-07944a364ae8 36 fields · synced Jun 9, 2026