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: SCS w/ S4 Wifi telemetry & S12/S19 bedside moning; EN language CD manual; CPU(SCNODE config must be determined) w/ 110V pwr & dual color LCD 24" mons w/ high res; 8 telemetry channels (single display required); Loc storage 600 days, 110V HP LaserJet printer; VERITAS analysis algorithm w/ 12-lead ECG interp, ext arrhythmia, 12-lead ST segment mon, & hemodynamic calc(required for opw/ hard wired pat mon slots); Full disclosure & SC Interface; Protocol mgr, per channel FDA UDI
Model / Reference: 901137 FDA UDI
Description: SCS w/ S4 Wifi telemetry & S12/S19 bedside moning; EN language CD manual; CPU(SCNODE config must be determined) w/ 110V pwr & dual color LCD 24" mons w/ high res; 8 telemetry channels (single display required); Loc storage 600 days, 110V HP LaserJet printer; VERITAS analysis algorithm w/ 12-lead ECG interp, ext arrhythmia, 12-lead ST segment mon, & hemodynamic calc(required for opw/ hard wired pat mon slots); Full disclosure & SC Interface; Protocol mgr, per channel FDA UDI

Identifiers

Catalog Number: SCSYS-IAE-CFFCA FDA UDI
Primary DI / UDI-DI: 00732094319064 FDA UDI
FDA Product Code: DPS FDA UDI
GMDN Term: Centralized patient monitor 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

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

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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 8e8d2a49-c8c5-4bbc-85af-d6ffc606d81a 35 fields · synced May 30, 2026