FDA.reportPublic FDA data

HEB in Control

Primary DI
00041220935765
Brand
HEB in Control
Company
H. E. BUTT GROCERY COMPANY
Model
BP3NB1-HEB
Published
2017-01-06
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10041220935762PackageGS16In Commercial Distribution
00041220935765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004122093576210041220935762
00041220935765000412209357650412209357650041220935765

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-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 not designed to be portable and is typically used bedside.

Regulatory Flags#

DUNS number
007924756
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041220048632H-E-B0412200486322020-07-27
00041220865468H-E-B inControlG202016-12-13
00197870203805H.E.BSix Days Sooner Pregnancy TestN/A2025-11-28
00197870203812H.E.BSix Days Sooner Pregnancy TestN/A2025-11-28
00633472000690H.E.BSix Days Sooner Pregnancy TestN/A2025-11-28
00041220569311H.E.B Advanced One Step Pregnancy Test2021-06-13
00041220575763H.E.B Advanced One Step Pregnancy Test2021-06-13
00041220575770H.E.B Advanced Early Result Pregnancy Test2021-06-25
00041220575794H.E.B Advanced Early Result Pregnancy Test2021-06-13
00197870203843H.E.BSix Days Sooner Pregnancy TestN/A2025-11-12
00197870203836H.E.BSix Days Sooner Pregnancy TestN/A2025-11-11
00041220723478H.E.B Advanced One Step Pregnancy Test2021-06-13
00197870203829H.E.BSix Days Sooner Pregnancy TestN/A2025-08-15
00633472000683H.E.BSix Days Sooner Pregnancy TestN/A2025-08-15
00041220245970H-E-B156-757-000156-757-0002016-09-12
00041220924837H-E-B156-878-000156-878-0002016-09-12
00041220823222HEB jelly PERSONAL LUBRICANT7W9261JC12021-12-08
00041220524556H.E.B Digital & Early Result Pregnancy Test 2021-06-25
00041220524563H.E.B Digital Pregnancy Test 2021-06-25
00197870071480H.E.BHEB DIG Wide-Tip & VIS PinkN/A2025-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04250413403578Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413403585Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413406456Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07
04250413406463Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07
06927709404608JALIPShenzhen Jamr Technology Co., Ltd.DXN2026-07-06
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06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
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06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
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