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, TMX428CP, 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, Programmable controller with ability to operate in manual mode FDA UDI
Model / Reference: 901085 FDA UDI
Description: Full Vision Trackmaster Treadmill, TMX428CP, 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, Programmable controller with ability to operate in manual mode FDA UDI

Identifiers

Catalog Number: 9922-018-53 FDA UDI
Primary DI / UDI-DI: 00732094274523 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 f57b4c9d-7b49-4e43-9096-4a60b814c240 35 fields · synced Jun 7, 2026