FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094338607
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901058
Catalog number
74WE
Device description
WFR CSM NIBP WA Braun Pro6000
Published
2020-08-26
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
00732094338591PackageGS11In Commercial Distribution
00732094338607PackageGS11In Commercial Distribution
00732094338614PackageGS11In Commercial Distribution
00732094338775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094338591007320943385917320943385910732094338591
00732094338607007320943386077320943386070732094338607
00732094338614007320943386147320943386140732094338614
00732094338775007320943387757320943387750732094338775

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid enhanced audio device, teaching-environmentA collection of battery-powered devices designed to be worn by a person (typically a child) wearing a compatible hearing aid to enhance the sound quality they receive by reducing background noise and/or room reverberation potentially found in a teaching environment (e.g., a school classroom). It uses a set frequency modulation (FM) between a transmitter worn by the speaker (e.g., a microphone worn be the teacher) and the FM receiver worn by the user. It typically consists of the FM receiver, a neck induction loop that emits the sound locally to the hearing aid, a battery charger, and various cables enabling connection to digital music devices.

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
true
Serial number
false
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

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Primary DI, Brand, Company table
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B693SICKBAY034600Sickbay Clinical PlatformMEDICAL INFORMATICS CORP.MWI2026-03-04
03615041990363Capsule SurveillancePhilips North America LLCMWI2026-01-08
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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
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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