FDA.report

Welch Allyn, Inc.

Primary DI
06932825396010
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901042
Catalog number
RPM-BP100
Device description
Welch Allyn Home Blood Pressure Monitor (1500 Series) with D-Ring Standard Wide Cuff (22-42cm), 4 Alkaline AA batteries. Home Blood Pressure Monitor may be used standalone, or in conjunction with the Welch Allyn Home Hypertension Program Clinical Portal and Patient Application. May also be integrated into third party Remote Patient Monitoring (RPM) solutions.
Published
2017-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06932825396010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06932825396010069328253960106932825396010

GMDN Terms

TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Sterilization Methods

Method

Contacts

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 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 DIBrandCompanyProduct codePublished
16942284601461SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601482SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601499SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601505SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601512SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601529SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601864SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
16942284601874SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
16942284601881SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601895SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
16942284601904SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601987SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
06951727602906MBUPAIShenzhen Changkun Technology Co., Ltd.DXN2026-03-24
26970392218445SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
06975164324436HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324535HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324542HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324610HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324627HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
00816042016356FORAFORA CARE INC.DXN2026-03-20
06953205995074Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995081Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995098Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995104Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995111Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995128Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995135Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995142Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
16953825910980lyobShenzhen Urion Technology Co., LtdDXN2026-03-20
00850047516039KismeTruth Remote Patient MonitoringRemote Smart Health, LLCDXN2026-03-19