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 no display monitors; 16 hard wired patient monitoring slots and 0 telemetry channels (dual display recommended); 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 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 no display monitors; 16 hard wired patient monitoring slots and 0 telemetry channels (dual display recommended); 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 FDA UDI

Identifiers

Catalog Number: SCSYS-IAD-DBFDX FDA UDI
Primary DI / UDI-DI: 00732094296396 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

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

Similar devices

Also classified as Centralized patient monitor.

Athena GTX Device Management Suite (ADMS) Software — Athena Gtx · Class II
Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC. · Class II
Infinity M300 Bedside Charger — Draeger Medical Systems, Inc. · Class II
Next Generation NetKonnect — Nihon Kohden Digital Health Solutions LLC · Class II
Xhibit — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
VIDCO NewtViewer - VIDCO Protocol — VIDCO, INC · Class II
Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC. · Class II
Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Welch Allyn, Inc.

Sources (1)

FDA UDI 7d9798fe-8b7b-4a4e-810f-f9634ea99c89 35 fields · synced May 30, 2026