FDA.reportPublic FDA data

Ozeri

Primary DI
20815817012689
Brand
Ozeri
Company
COMMONPATH LLC
Model
BP6T
Catalog number
BP6T
Device description
Ozeri Cardio Tech, Travel series. LEss than 1" inch(2.5cm) thick and 3.5 oz(100g). New MWI(Measure white inflate) technology. 399 x 3 users.
Published
2017-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10815817012682PackageGS11In Commercial Distribution
20815817012689PackageGS118In Commercial Distribution
00815817012685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081581701268210815817012682
2081581701268920815817012689
00815817012685008158170126858158170126850815817012685

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, fingerAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic finger-cuff inflation and measurement cycles. The cuff detects minute arterial volume changes in conjunction with an inflatable bladder which exerts pressure (counterpressure) just sufficient to equal the arterial pressure. The device typically displays current heart rate in addition to systolic and diastolic blood pressures. 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18772991296support@ozeri.com

Regulatory Flags#

DUNS number
963223677
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815817012456Ozeri BP8H2017-05-15
00815817014153OzeriTH1-BL2021-11-01
10815817014150OzeriTH1-BL2021-11-01
00815817013309OzeriBP6T2020-09-03
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
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
06953825911942CofoeShenzhen Urion Technology Co., LtdDXN2026-10-20
06953825911928CofoeShenzhen Urion Technology Co., LtdDXN2026-10-19
06953825911904saidianShenzhen Urion Technology Co., LtdDXN2026-10-14
06974560230655ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-14
06953825911881N/AShenzhen Urion Technology Co., LtdDXN2026-10-13
06974560230648ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-13
00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
06933257920187Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
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
06973826012318AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
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
06973826012370AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012387AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09