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; Italian language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 16 hard wired patient monitoring slots and 8 telemetry channels (dual display required); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment mo FDA UDI
Model / Reference: 901137 FDA UDI
Description: Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Italian language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 16 hard wired patient monitoring slots and 8 telemetry channels (dual display required); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment mo FDA UDI

Identifiers

Catalog Number: SCSYS-IED-JBFDX FDA UDI
Primary DI / UDI-DI: 00732094262155 FDA UDI
510(k) Number: K131929 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

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Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

Yes

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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: 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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Cleared under the same submission

K131929 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: Welch Allyn, Inc.

Sources (1)

FDA UDI 46022f5c-a90b-424b-aa47-a9c69c0e5a78 36 fields · synced May 30, 2026