FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094335408
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901058
Catalog number
75RE
Device description
WIFI CSM NIBP Mas RRp Braun Pro6000
Published
2023-04-26
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
00732094335583PackageGS11In Commercial Distribution
00732094335590PackageGS11In Commercial Distribution
00732094335606PackageGS11In Commercial Distribution
00732094335613PackageGS11In Commercial Distribution
00732094335620PackageGS11In Commercial Distribution
00732094335637PackageGS11In Commercial Distribution
00732094335644PackageGS11In Commercial Distribution
00732094343397PackageGS11In Commercial Distribution
00732094335408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094335583007320943355837320943355830732094335583
00732094335590007320943355907320943355900732094335590
00732094335606007320943356067320943356060732094335606
00732094335613007320943356137320943356130732094335613
00732094335620007320943356207320943356200732094335620
00732094335637007320943356377320943356370732094335637
00732094335644007320943356447320943356440732094335644
00732094343397007320943433977320943433970732094343397
00732094335408007320943354087320943354080732094335408

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.

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

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
08719689142124QMAPP Fysicon B.V.MWI2026-05-19
08719689142131QMAPP Fysicon B.V.MWI2026-05-19
08719689142162QMAPP Fysicon B.V.MWI2026-05-19
08719689142179QMAPP Fysicon B.V.MWI2026-05-19
10197344213245MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08
10197344213252MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08
10197344213238MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-04-23
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.MWI2026-03-18
B153301010AirStrip ONE Client iOSAirstrip Technologies, Inc.MWI2026-03-18
B153301020AirStrip ONE Client AndroidAirstrip Technologies, Inc.MWI2026-03-18
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10884838115092MR Patient Care Pediatric SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
17540262100143Change Healthcare Cardiology HemoChange Healthcare Canada CompanyMWI2026-03-09
17540262170047Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyMWI2026-03-09
10884838129938MR Patient Care Temperature Sensor JacketPhilips Medizin Systeme Böblingen GmbHMWI2026-01-06
14250892908509JaegerJaeger Medical GmbHMWI2025-11-24
14250892908936JaegerJaeger Medical GmbHMWI2025-11-24
34250892909012JaegerJaeger Medical GmbHMWI2025-11-24
34250892909029JaegerJaeger Medical GmbHMWI2025-11-24
34250892908367JaegerJaeger Medical GmbHMWI2025-10-31
34250892908541JaegerJaeger Medical GmbHMWI2025-10-31
34250892908589JaegerJaeger Medical GmbHMWI2025-10-31
10884838111407MR Patient Care Temperature Sensor JacketPhilips Medizin Systeme Böblingen GmbHMWI2025-05-30
10884838117874MR Patient Care Pediatric SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120805MR Patient Care Infant NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120812MR Patient Care Pediatric NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120829MR Patient Care Small Adult NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120836MR Patient Care Adult NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120843MR Patient Care Adult-Long NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120867MR Patient Care Large Adult NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22