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Welch Allyn, Inc.

FDA UDI

Class II (US FDA UDI)

by Welch Allyn, Inc.

Identity

Trade Name
Welch Allyn, Inc. FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
Surveyor S12 GEN2 Patient Monitoring System - Surveyor Sp02, ECG, Dual Temp, NIBP, IBP 1/2, CO2, starter kit, resistive color touchscreen 11.6"" display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; US/Canada power cord; AM12 Wired Acquisition Module with AHA 12-lead lead set with snap ends and 1 AHA 5 wire ECG patient cable with clip ends; Edwards invasive blood pressure cable (qty 2) and Y cable; Cardiac output cable and in-line temperature probe, Edwards (1 eac FDA UDI
Model / Reference
901138 FDA UDI
Description
Surveyor S12 GEN2 Patient Monitoring System - Surveyor Sp02, ECG, Dual Temp, NIBP, IBP 1/2, CO2, starter kit, resistive color touchscreen 11.6"" display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; US/Canada power cord; AM12 Wired Acquisition Module with AHA 12-lead lead set with snap ends and 1 AHA 5 wire ECG patient cable with clip ends; Edwards invasive blood pressure cable (qty 2) and Y cable; Cardiac output cable and in-line temperature probe, Edwards (1 eac FDA UDI

Identifiers

Catalog Number
SUR12-RAG-DAABX FDA UDI
Primary DI / UDI-DI
00732094294262 FDA UDI
FDA Product Code
MHX FDA UDI
GMDN Term
General-purpose multi-parameter bedside 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General-purpose multi-parameter bedside 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 General-purpose multi-parameter bedside monitor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Welch Allyn, Inc.

Sources (1)

  • FDA UDI 0a84603a-289b-4422-acdc-18ad2e883cb1 35 fields · synced Jun 8, 2026