FDA.reportPublic FDA data

Digital Blood Monitors

Primary DI
00616784709628
Brand
Digital Blood Monitors
Company
Dynarex Corporation
Model
7096
Device description
Upper Arm
Published
2021-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K181104000
K260260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181104000Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm StyleShenzhen Combei Technology Co., Ltd.2018-08-29DXN
K260260000Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)Honsun (Nantong) Co., Ltd.2026-04-28DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784709635PackageGS15In Commercial Distribution
00616784709628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784709635006167847096356167847096350616784709635
00616784709628006167847096286167847096280616784709628

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.

Regulatory Flags#

DUNS number
008124539
Device count
1

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