FDA.reportPublic FDA data

AUPO

Primary DI
06955647600080
Brand
AUPO
Company
FUDAKANG INDUSTRIAL CO., LTD.
Model
FT-B13W
Device description
Blood Pressure Monitor
Published
2020-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16955647600087PackageGS16In Commercial Distribution
26955647600084PackageGS148In Commercial Distribution
06955647600080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695564760008716955647600087
2695564760008426955647600084
06955647600080069556476000806955647600080

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
544522665
Device count
1
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16955647600049PREXBT-A31-BT2020-09-29
06955647600066FDKBT-A41CN-BT2020-10-20
06955647600073AUPOFT-F212020-11-23
06955647600011FDKBT-A11CN2020-09-15
16955647600070AUPOFT-F212020-11-23
16955647600087AUPOFT-B13W2020-11-23
16955647600063FDKBT-A41CN-BT2020-10-20
26955647600053PREXBT-A31-BT2020-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911706SAKERShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911720N/AShenzhen Urion Technology Co., LtdDXN2026-08-01
00885403529644Acumen IQ CuffBecton, Dickinson And CompanyDXN2026-07-31
00885403529651Acumen IQ CuffBecton, Dickinson And CompanyDXN2026-07-31
00885403533191Acumen IQ PlusBecton, Dickinson And CompanyDXN2026-07-31
00885403533207VitaWaveBecton, Dickinson And CompanyDXN2026-07-31
00885403529637Acumen IQBecton, Dickinson And CompanyDXN2026-07-29
00885403529668Acumen IQBecton, Dickinson And CompanyDXN2026-07-29
00885403529774ClearSight JrBecton, Dickinson And CompanyDXN2026-07-29
00885403529781ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529798ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529811ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529828VitaWaveBecton, Dickinson And CompanyDXN2026-07-29
00194346614035equateWAL-MART STORES, INC.DXN2026-07-28
06953825911683SAKER UltraShenzhen Urion Technology Co., LtdDXN2026-07-27
06953825911645N/AShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911652ANOVATORShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911669SPASTACISEShenzhen Urion Technology Co., LtdDXN2026-07-24
06932825306057CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
06932825306064CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
00073796318321WIDE-RANGE D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00073796392437SMALL D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00816042016516FORAFORA CARE INC.DXN2026-07-20
00898939002758FORAFORA CARE INC.DXN2026-07-20
06953825911515N/AShenzhen Urion Technology Co., LtdDXN2026-07-16
00850044118670iHealthiHealth Labs Inc.DXN2026-07-14
00850044118687iHealthiHealth Labs Inc.DXN2026-07-14
00850078377234iHealthiHealth Labs Inc.DXN2026-07-14
06953825911416N/AShenzhen Urion Technology Co., LtdDXN2026-07-13