FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094313871
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901138
Catalog number
SUR12-UCC-XXAAX
Device description
"Surveyor S12 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, No IBP, resistive color touchscreen 11.6"" display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; UK power cord; AHA 5 wire ECG patient cable with clip ends; No invasive blood pressure cable; No cardiac output cable; Internal thermal printer (includes starter pack of thermal paper roll, 1.97 in. x 100 ft., (50mm x 30.48m) 10 rolls); LAN; No mounting options"
Published
2019-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123556000MORTARA SURVEYOR PATIENT MONITORMortara Instrument, Inc.2013-03-22MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094313871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094313871007320943138717320943138710732094313871

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-patient intensive/general healthcare physiologic monitoring systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags#

DUNS number
198227881
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094323931Welch Allyn, Inc.901139S2-P-AXX-XXX2023-08-25
00732094272222Welch Allyn, Inc.90114533193-001-512019-09-26
00732094262551Welch Allyn, Inc.901011SCNODE-DEB-CXXXX2019-09-25
00732094288773Welch Allyn, Inc.9011441081912020-11-10
00732094288780Welch Allyn, Inc.9011441081902020-11-10
00732094272086Welch Allyn, Inc.90109541000-032-572020-02-19
00732094272154Welch Allyn, Inc.90114533193-106-532019-09-26
00732094272161Welch Allyn, Inc.90114533193-106-522019-09-26
00732094272178Welch Allyn, Inc.90114533193-106-512019-09-26
00732094271782Welch Allyn, Inc.901007ACC-ELI280-A2019-07-24
00732094265125Welch Allyn, Inc.901134ESWK-AEB-BXXXX2019-09-17
00732094271812Welch Allyn, Inc.901095ACC-BUR280-B2019-09-13
00732094272116Welch Allyn, Inc.90109541000-031-572019-09-13
00732094271768Welch Allyn, Inc.901007ACC-ELI380-A2019-09-12
00732094322866Welch Allyn, Inc.901134ESCRIBE-CAX-DXACB2019-07-22
00732094322873Welch Allyn, Inc.901134ESCRIBE-CAX-CXXXX2019-07-22
00732094322880Welch Allyn, Inc.901134ESCRIBE-CAX-CXACX2019-07-22
00732094322897Welch Allyn, Inc.901134ESCRIBE-CAX-CXACA2019-07-22
00732094322903Welch Allyn, Inc.901134ESCRIBE-BEX-CXXXA2019-07-22
00732094322910Welch Allyn, Inc.901134ESCRIBE-BEX-CXXCA2019-07-22

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