Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094261806
• Version / Model: 901138
• Catalog Number: SUR12-FCB-AXXAX
• Company Name: WELCH ALLYN, INC.
• Labeler DUNS: 198227881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-01
• Public Version: 2
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: 2cc7e513-11d1-41c9-b450-654773de8bcc

Device Description

Surveyor S12 GEN2 Patient Monitoring System - Surveyor Sp02, ECG, Dual Temp, NIBP, IBP 1/2, resistive color touchscreen 11.6 in. display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; UK power cord; IEC 3 wire ECG patient cable with clip ends; Becton-Dickson invasive blood pressure cable; No cardiac output cable; No printer; LAN; No mounting options

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37595	Multiple-patient intensive/general healthcare physiologic monitoring system	An assembly of electrically-powered devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of more than one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and bedside patient monitors to provide data from each patient; it often includes programmable alarms, portable radio transmitters (with sensors), receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00732094261806	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123556	000