FDA.reportPublic FDA data

AGE

Primary DI
06958682800149
Brand
AGE
Company
AGELESS HEALTH INDUSTRIAL LIMITED
Model
BW-603
Device description
Wrist blood pressure monitor: Small, portable, easy to carry, measuring the arterial blood pressure of wrist at any time and place. Wrist sphygmomanometer isconvenient not to take off the coat, especially in winter
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
K151281000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151281000AGE Automatic Wrist Blood Pressure MonitorDongguan Ageless Health Industrial Co., Ltd.2015-06-30DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06958682800149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06958682800149069586828001496958682800149

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
06958682800163AGEBA-8022017-10-29
06958682800187AGEBA-8032017-10-29
06958682800224AGEBA-8112017-10-29
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

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Primary DI, Brand, Company table
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