FDA.reportPublic FDA data

koogeek

Primary DI
06947468535771
Brand
koogeek
Company
Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
Model
BP2
Published
2018-11-06
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K134029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K134029000BELTER BLOOD PRESSURE METERShenzhen Belter Health Measurement and Analysis TE2014-07-25DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16947468535778PackageGS11In Commercial Distribution
26947468535775PackageGS140In Commercial Distribution
06947468535771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694746853577816947468535778
2694746853577526947468535775
06947468535771069474685357716947468535771

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
529903321
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947468500519RITE AIDTE-972023-09-20
16947468500363RITE AIDTE-972023-09-20
06947468500502BytechT30-BEE2023-06-26
16947468500356BytechT30-BEE2023-06-26
06947468500496RITE AIDTE-972023-05-27
16947468500349RITE AIDTE-972023-05-27
06947468500489 NOTE-792023-05-23
16947468500332 NOTE-792023-05-23
06947468500441BluedotTE-792023-03-29
16947468500325BluedotTE-792023-03-29
06947468500434CARE TOUCHTE-912022-11-14
16947468500318CARE TOUCHTE-912022-11-14
06947468500403biotricityePA-13B42022-08-18
06947468500427biotricityTE-912022-08-18
16947468500295biotricityePA-13B42022-08-18
16947468500301biotricityTE-912022-08-18
06947468500397RITE AIDTE-972022-08-09
16947468500288RITE AIDTE-972022-08-09
06947468500373belterETE-107B42022-03-24
06947468500366KainkriptTE-952022-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
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06933257926066YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257931688YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947016YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947023Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947030YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06973826012240AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012257AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012264AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012271AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012288AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012295AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012301AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
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06973826012325AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012332AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012349AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012356AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012363AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
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06973826012387AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012394AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012400AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012417AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
04250413405657ABPMpro SoftwareSOMNOmedics AGDXN2026-10-07
10884450480615Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2026-10-07
00634782102357ADView® 2.6AMERICAN DIAGNOSTIC CORPDXN2026-10-06
00198953009567Carescape ONEGE Healthcare Finland OyDXN2026-10-04
00810226060166Easy@Home Blood Pressure MonitorEASY HEALTHCARE CORPORATIONDXN2026-09-30