FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094335392
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901058
Catalog number
75RT
Device description
WIFI CSM NIBP Mas RRp SureTemp
Published
2022-10-03
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
MWIMonitor, physiological, patient (without arrhythmia detection or alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094335507PackageGS11In Commercial Distribution
00732094335514PackageGS11In Commercial Distribution
00732094335521PackageGS11In Commercial Distribution
00732094335538PackageGS11In Commercial Distribution
00732094335545PackageGS11In Commercial Distribution
00732094335552PackageGS11In Commercial Distribution
00732094335569PackageGS11In Commercial Distribution
00732094335576PackageGS11In Commercial Distribution
00732094335392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094335507007320943355077320943355070732094335507
00732094335514007320943355147320943355140732094335514
00732094335521007320943355217320943355210732094335521
00732094335538007320943355387320943355380732094335538
00732094335545007320943355457320943355450732094335545
00732094335552007320943355527320943355520732094335552
00732094335569007320943355697320943355690732094335569
00732094335576007320943355767320943355760732094335576
00732094335392007320943353927320943353920732094335392

GMDN Terms#

Term, Definition table
TermDefinition
Prostate electrolytic therapy systemA mobile assembly of mains electricity (AC-powered) devices designed to treat benign prostatic hyperplasia (BPH) and prostatitis through transurethral electrochemical treatment causing liquefaction necrosis to the diseased peri-urethral prostate. It typically consists of a power supply that provides a low output level (e.g., less than 30 volts) and an adjustable output current [e.g., 0 to 100 milliampere (mA)], operator's console, monitoring systems, alarms, software, and an electrolytic therapeutic catheter.

Contacts#

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

Regulatory Flags#

DUNS number
198227881
Device count
1
Serial number
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

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Primary DI, Brand, Company table
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