FDA.reportPublic FDA data

Ozeri

Primary DI
00815817013309
Brand
Ozeri
Company
COMMONPATH LLC
Model
BP6T
Device description
"Travel series BPM. LEss than 1"" inch(2.5cm) thick and 3.5 oz(100g). New MWI(Measure white inflate) technology. 399 x 3 users."
Published
2020-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
10815817013306PackageGS11In Commercial Distribution
20815817013303PackageGS118In Commercial Distribution
00815817013309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081581701330610815817013306
2081581701330320815817013303
00815817013309008158170133098158170133090815817013309

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.

Contacts#

Phone, Email table
PhoneEmail
18772991296support@ozeri.com

Regulatory Flags#

DUNS number
963223677
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815817012456Ozeri BP8H2017-05-15
00815817014153OzeriTH1-BL2021-11-01
10815817014150OzeriTH1-BL2021-11-01
10815817013306OzeriBP6T2020-09-03
00815817013484OzeriTH1-WNT12020-08-27
10815817013481OzeriTH1-WNT12020-08-27
00815817013293OzeriBP9WBP9W2020-08-06
00815817012685Ozeri BP6TBP6T2017-05-23
00815817012746OzeriBP3T2017-10-26
00815817013255OzeriBP3T2019-10-27
20815817013259OzeriBP3T2019-10-27
20815817012450Ozeri BP8H2017-05-15
20815817012689Ozeri BP6TBP6T2017-05-23
20815817012740OzeriBP3T2017-10-26
70000010001001OzeriZB132016-11-04
70000010001002OzeriZB13-W2016-11-10
00815817012326OzeriZB132017-02-17
00815817012333OzeriZB13-W2017-02-17

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