BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

IDEA Health

DI: G057IDBP8080 · Model: ID-BP808 · IDEA HEALTH LLC

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

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Basic Information

Brand Name: IDEA Health
Primary DI: G057IDBP8080
Version / Model: ID-BP808
Company Name: IDEA HEALTH LLC
Labeler DUNS: 117854485
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2021-04-08
Public Version: 1
Public Version Date: 2021-04-16
Public Version Status: New
Public Device Record Key: 2e78539d-3d7d-44a5-8f57-159c1c659338

Device Characteristics

Single Use: No
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: No
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45617	Automatic-inflation electronic sphygmomanometer, portable, arm/wrist	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	G057IDBP8081	HIBCC	individual box	1	In Commercial Distribution
Primary	G057IDBP8080	HIBCC
Package	G057IDBP8082	HIBCC	10-piece carton box	10	In Commercial Distribution

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 5 – 40 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 15 – 90 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -20 – 60 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 0 – 93 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: 0 – 5 KiloPascal
Type: Handling Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal