FDA.reportPublic FDA data

IDEA Health

Primary DI
G057IDBP8080
Brand
IDEA Health
Company
IDEA HEALTH LLC
Model
ID-BP808
Published
2021-04-08
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G057IDBP8081PackageHIBCC1In Commercial Distribution
G057IDBP8082PackageHIBCC10In Commercial Distribution
G057IDBP8080PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure0 KiloPascal5 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
117854485
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G057IDWS8090IDEA HealthID-WS8092021-04-08
G057IDBP8081IDEA HealthID-BP8082021-04-08
G057IDWS8091IDEA HealthID-WS8092021-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800096401772Auto Blood Pressure MeterSEERS.Co.,LtdDXN2026-05-13
10850047516036KismeTruth Remote Patient MonitoringRemote Smart Health, LLCDXN2026-03-26
10840935111580Adult Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
10840935111597Adult Plus Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
10840935111603Large Adult Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
08690020003017VitalScan ANSMedeia, Inc.DXN2025-02-05
10884450360634Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2024-09-06
09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXN2024-07-10
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2024-06-19
10884450388164Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2023-03-03
10840935110002SunTech MedicalSUNTECH MEDICAL, INC.DXN2022-12-14
09120073932990CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXN2022-06-09
10884450385163Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-06-08
10884450323264Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-03-04
10884450619282Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-28
10884450619299Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-28
10884450621155Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-28
10884450371777Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-18
10884450371739Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2021-10-12
10884450372781Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2021-07-21
10840935109662Oscar 2SUNTECH MEDICAL, INC.DXN2021-04-09
10840935109679Oscar 2SUNTECH MEDICAL, INC.DXN2021-04-09
10840935109686Oscar 2SUNTECH MEDICAL, INC.DXN2021-04-09
10884450544157Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2021-01-27
10193489012903MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-16
10193489012927MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-16
10193489012965MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-16
10193489012934MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-14
10193489012972MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-14
10840935109396SunTechSUNTECH MEDICAL, INC.DXN2020-11-19