FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094335385
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901058
Catalog number
75RX
Device description
WIFI CSM NIBP Mas RRp
Published
2023-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00732094335460PackageGS11In Commercial Distribution
00732094335385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094335460007320943354607320943354600732094335460
00732094335385007320943353857320943353850732094335385

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094055245Welch Allyn, Inc.901001SM25512026-03-06
00887761976283Life2000MS-01-01252026-02-09
00887761978041Life2000MS-01-01212026-02-09
00732094360363Welch Allyn, Inc.901144QS-6AA-AEAAA2026-02-03
00732094360370Welch Allyn, Inc.901144XSCRIBE-6AA-ACAAA2026-02-03
00732094360295Welch Allyn, Inc.901204 v7.4.2E100012025-12-18
00732094357929Welch Allyn, Inc.90102671-XM2LXE2025-11-25
00732094358933Welch Allyn, Inc.901203C360KIT95RXTBWLJBP2025-11-24
00732094358957Welch Allyn, Inc.901203C360KIT95MXTBWLJBP2025-11-24
00732094358971Welch Allyn, Inc.901203C360KIT95CXTBWLJBP2025-11-24
00732094358988Welch Allyn, Inc.901203C360KIT95CXTBMBJX2025-11-24
00732094237740Welch Allyn, Inc.901049CP150A2025-09-22
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094356380Welch Allyn, Inc.9010069293-046-062025-09-22
00732094356397Welch Allyn, Inc.9010069293-046-052025-09-22
00732094356403Welch Allyn, Inc.9010069293-046-042025-09-22
00732094356410Welch Allyn, Inc.9010069293-046-032025-09-22
00732094309225Welch Allyn, Inc.90105744XT2021-04-26
06932825304237Welch Allyn, Inc.9011232000 PLUS-A2025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838113770MR Patient Care Adult SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
00884838100978MR Patient Care Pediatric SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
B693SICKBAY034600Sickbay Clinical PlatformMEDICAL INFORMATICS CORP.MWI2026-03-04
03615041990363Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990394Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990431Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990455Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990479Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990486Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990509Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990516Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990547Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990554Capsule SurveillancePhilips North America LLCMWI2026-01-08
00199874784175MedibluMEDIBLU MEDICAL LLCMWI2025-12-23
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.MWI2025-12-10
00732094358933Welch Allyn, Inc.WELCH ALLYN, INC.MWI2025-11-24
00732094358957Welch Allyn, Inc.WELCH ALLYN, INC.MWI2025-11-24
00732094358971Welch Allyn, Inc.WELCH ALLYN, INC.MWI2025-11-24
00732094358988Welch Allyn, Inc.WELCH ALLYN, INC.MWI2025-11-24
03615040002456Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002470Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002487Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002494Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002500Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002517Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002524Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002531Capsule Vitals PLusPhilips North America LLCMWI2025-07-31
03615040002562Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
B693SICKBAY034500Sickbay Clinical PlatformMedical Informatics Corp.MWI2025-07-28
07045432118377NeoBeat Charging StandLaerdal Medical ASMWI2025-07-25