FDA.reportPublic FDA data

AGE

Primary DI
06958682800224
Brand
AGE
Company
AGELESS HEALTH INDUSTRIAL LIMITED
Model
BA-811
Device description
Arm type blood pressure monitor, It can can correctly measure arterial blood pressure, must take off the coat for measurement, The cuff of the sphygmomanometer is attached to the left arm,It is very suitable for use in the family
Published
2017-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123882000AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITORAgeless Health Industrial2013-08-14DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06958682800224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06958682800224069586828002246958682800224

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421298453
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06958682800057AGEBW-6012017-10-29
06958682800071AGEBW-606S2017-10-29
06958682800088AGEBA-8012017-10-29
06958682800101AGEBA-8062017-10-29
06958682800125AGEBW-6022017-10-29
06958682800149AGEBW-6032017-10-29
06958682800163AGEBA-8022017-10-29
06958682800187AGEBA-8032017-10-29
06958682800255AGEBA-8122017-10-29
06958682800279AGEBA-8132017-10-29
06958682800286AGEBT-3012017-10-29
06958682800293AGEBT-3022017-10-29
06958682800309AGEBT-3032017-10-29
06958682800316AGEBT-3052017-10-29
06958682800323AGEBT-3062017-10-29
06958682800330AGEBT-3082017-10-29
06958682800347AGEBT-3112017-10-29
06958682800354AGEBT-3182017-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911225AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911232AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
06976528061608Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06976528061615Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06932825303216TeleRPMGuangdong Transtek Medical Electronics Co.,LtdDXN2026-06-02
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06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
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06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
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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