FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094347180
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901137
Catalog number
SCNODE-DAA-EXXEX
Device description
ENG. 110V custom sl- CONTROL W DISPLAY
Published
2023-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094347180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094347180007320943471807320943471800732094347180

GMDN Terms#

Term, Definition table
TermDefinition
Centralized patient monitorA mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].

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
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
00732094322927Welch Allyn, Inc.901134ESCRIBE-BEX-CXACA2019-07-22
00732094322934Welch Allyn, Inc.901134ESCRIBE-BEX-CXAAA2019-07-22
00732094322941Welch Allyn, Inc.901134ESCRIBE-BAX-DXACX2019-07-22
00732094322958Welch Allyn, Inc.901134ESCRIBE-BAX-DXACB2019-07-22
00732094322965Welch Allyn, Inc.901134ESCRIBE-BAX-CXXXX2019-07-22
00732094322972Welch Allyn, Inc.901134ESCRIBE-BAX-CXACB2019-07-22
00732094322989Welch Allyn, Inc.901134ESCRIBE-BAX-CXACA2019-07-22
00732094322996Welch Allyn, Inc.901134ESCRIBE-BAX-CXAAX2019-07-22
00732094323009Welch Allyn, Inc.901134ESCRIBE-AEX-CXXXX2019-07-22
00732094323016Welch Allyn, Inc.901134ESCRIBE-AEX-CXXXA2019-07-22
00732094323023Welch Allyn, Inc.901134ESCRIBE-AEX-CXAXA2019-07-22
00732094323030Welch Allyn, Inc.901134ESCRIBE-AEX-CXAAA2019-07-22
00732094323047Welch Allyn, Inc.901134ESCRIBE-AAX-DXXXX2019-07-22
00732094323054Welch Allyn, Inc.901134ESCRIBE-AAX-CXXXX2019-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyMHX2026-04-15
00840682144292CARESCAPEGe Medical Systems Information Technologies, Inc.MHX2025-06-04
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B353UB25501UbiqVue MultiparameterLifesignals, Inc.MHX2024-11-29
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMHX2024-06-07
B353UA2550BG1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550C1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550MR1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550RB1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550S1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550R1UbiqVue Lifesignals, Inc.MHX2024-05-06
B353UB15501UbiqVue MultiparameterLifesignals, Inc.MHX2024-05-06
00382830062947Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062954Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062961Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062985Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063005Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063012Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063029Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyMHX2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyMHX2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyMHX2023-04-19
00195278466662E-EEGXGE Healthcare Finland OyMHX2022-07-01
00195278466679N-EEGXGE Healthcare Finland OyMHX2022-07-01
00840682146111CARESCAPE B650GE Healthcare Finland OyMHX2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyMHX2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyMHX2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.MHX2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.MHX2022-04-12