FDA.reportPublic FDA data

HealthSmart

Primary DI
00767056041745
Brand
HealthSmart
Company
D-M-S HOLDINGS, INC.
Model
04-174-021
Catalog number
04-174-021
Device description
SELF TAKING HOME BP UNIT BLACK ADULT
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DXQBlood Pressure Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082542000ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-ACardicare Company, Ltd.2008-09-17DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10767056041742PackageGS16In Commercial Distribution
30767056041746PackageGS14In Commercial Distribution
00767056041745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076705604174210767056041742
3076705604174630767056041746
00767056041745007670560417457670560417450767056041745

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
062028220
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041298995326DMI619-5140-19002026-06-05
00767056160026MABIS01-160-02101-160-0212016-09-23
00767056160088MABIS01-160-08101-160-0812016-09-23
00767056160156MABIS01-160-15101-160-1512016-09-23
00767056160200MABIS01-160-20101-160-2012016-09-23
00767056160217MABIS01-160-21101-160-2112016-09-23
00767056160248MABIS01-160-24101-160-2412016-09-23
00767056410176MABIS09-141-01709-141-0172016-09-23
00767056110212MABIS01-110-02101-110-0212016-09-23
00767056234017MABIS05-234-01005-234-0102016-09-23
00767056300118MABIS01-130-01101-130-0112016-09-23
00767056300156MABIS01-130-01501-130-0152016-09-23
00767056300163MABIS01-130-01601-130-0162016-09-23
00767056322059MABIS05-223-06005-223-0602016-09-23
00767056400115MABIS01-140-01101-140-0112016-09-23
00767056400139MABIS01-140-01301-140-0132016-09-23
00767056400153MABIS01-140-01501-140-0152016-09-23
00767056400160MABIS01-140-01601-140-0162016-09-23
00767056400177MABIS01-140-01701-140-0172016-09-23
00767056550117MABIS01-155-01101-155-0112016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975185470358LightningWenzhou Kangshun Medical Devices CO.,LTDDXQ2026-08-08
06971996170005MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170012MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170029MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170036MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170043MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170050MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170067MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170074MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170081MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170098MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170104MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170111MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170128MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170135MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170142MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170159MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170166MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170173MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170180MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170197MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170203MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170210MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170227MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170234MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170241MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170258MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170265MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170272MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170289MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07