Welch Allyn, Inc.

FDA UDI

Class II (US FDA UDI)

by Welch Allyn, Inc.

Identity

Trade Name: Welch Allyn, Inc. FDA UDI
Generic Name: Electrocardiograph, professional, multichannel FDA UDI
Device Name: Full Vision Trackmaster Treadmill, TMX428, following features included: Treadmill test device, Cable to CPU, 500 lb. weight capacity, 22" in. x 63" in. running belt and safety handrails, 0.5-12 mph speed, 0-25% elevation, 6 HP at peak high-torque drive, Emergency stop button and patient safety tether, NEMA power cord, Operator and service manual, US Power Cord, detachable, Voltage 110V FDA UDI
Model / Reference: 901085 FDA UDI
Description: Full Vision Trackmaster Treadmill, TMX428, following features included: Treadmill test device, Cable to CPU, 500 lb. weight capacity, 22" in. x 63" in. running belt and safety handrails, 0.5-12 mph speed, 0-25% elevation, 6 HP at peak high-torque drive, Emergency stop button and patient safety tether, NEMA power cord, Operator and service manual, US Power Cord, detachable, Voltage 110V FDA UDI

Identifiers

Catalog Number: 9922-018-51 FDA UDI
Primary DI / UDI-DI: 00732094274547 FDA UDI
FDA Product Code: DPS FDA UDI
GMDN Term: Electrocardiograph, professional, multichannel FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

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Category: Electrocardiograph, professional, multichannel

Welch Allyn, Inc. by Welch Allyn, 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: Welch Allyn, Inc.

Sources (1)

FDA UDI 49f77393-7ce3-4bef-94a9-b7af6b1a391b 35 fields · synced May 30, 2026