Welch Allyn, Inc.

FDA UDI

Class II (US FDA UDI)

by Welch Allyn, Inc.

Identity

Trade Name: Welch Allyn, Inc. FDA UDI
Generic Name: Centralized patient monitor FDA UDI
Device Name: Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24" monitors with high resolution; 8 hard wired patient monitoring slots and 0 telemetry channels (single display required); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12- lead ECG inter FDA UDI
Model / Reference: 901137 FDA UDI
Description: Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24" monitors with high resolution; 8 hard wired patient monitoring slots and 0 telemetry channels (single display required); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12- lead ECG inter FDA UDI

Identifiers

Catalog Number: SCSYS-IAB-ADFCA FDA UDI
Primary DI / UDI-DI: 00732094351262 FDA UDI
FDA Product Code: MHX FDA UDI
GMDN Term: Centralized patient monitor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1025 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

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Manufacturing Date

Yes

FDA UDI

Category: Centralized patient monitor

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 dab8a540-c6dc-49ab-a5f7-f48cf325dd6a 35 fields · synced May 31, 2026