FDA.reportPublic FDA data

Omron Heart Guide Wrist Blood Pressure Monitor, Large

Primary DI
00073796268022
Brand
Omron Heart Guide Wrist Blood Pressure Monitor, Large
Company
Omron Healthcare, Inc.
Model
BP8000-L
Catalog number
BP8000-L
Device description
Wearable Wrist Blood Pressure Monitor with Fitness and Sleep Tracking
Published
2019-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190693000HEM-6410T-ZL Wrist Blood Pressure MonitorOmron Healthcare, Inc.2019-04-17DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10073796268029PackageGS14In Commercial Distribution
20073796268026PackageGS14In Commercial Distribution
00073796268022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007379626802910073796268029
2007379626802620073796268026
00073796268022000737962680220737962680220073796268022

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity5 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-800-634-4350ohiquality@omron.com

Regulatory Flags#

DUNS number
054318779
Device count
1
Lot or batch
true
Serial number
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00073796760069Upper Arm Blood Pressure MonitorHEM-7600T-CD6HEM-7600T-CD62025-07-15
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Primary DI, Brand, Company table
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