FDA.reportPublic FDA data

CVS Health

Primary DI
00050428252994
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
800231
Device description
Blood Pressure Monitor
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10050428252991PackageGS112In Commercial Distribution
00050428252994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005042825299110050428252991
00050428252994000504282529940504282529940050428252994

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-536-0366info@beurer.com

Regulatory Flags#

DUNS number
062312574
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428044940CVS6158032026-05-26
00050428045770CVS6162732026-05-26
00050428046715CVS6162742026-05-26
00050428344781CVS0504283447812026-05-25
00050428250181CVS Health4969912023-09-01
00050428340769CVS Health 0504283407692026-05-20
00050428490730CVS Health5645702021-04-08
00050428000021CVS Health 0504280000212026-05-19
00050428373927CVS Health 9377672026-04-27
00050428142530CVS0504281425302026-04-23
00050428258590CVS Health8931212020-08-24
00050428265499CVS Health2414832020-02-28
00050428267189CVS Health9356862020-08-24
00050428279472CVS Health9843012020-03-02
00050428290118CVS Health8931262020-08-24
00050428307274CVS Health9356832020-08-24
00050428308615CVS Health5426302019-09-30
00050428311097CVS Health9356852020-08-24
00050428347928CVS Health8931252020-08-24
00050428354506CVS Health9843002019-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
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B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
08800096401772Auto Blood Pressure MeterSEERS.Co.,LtdDXN2026-05-13
10850047516036KismeTruth Remote Patient MonitoringRemote Smart Health, LLCDXN2026-03-26
10840935111580Adult Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
10840935111597Adult Plus Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
10840935111603Large Adult Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
08690020003017VitalScan ANSMedeia, Inc.DXN2025-02-05
10884450360634Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2024-09-06
09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXN2024-07-10