FDA.reportPublic FDA data

Avantia BPM-70 Automatic Blood Pressure Monitor

Primary DI
00775757079301
Brand
Avantia BPM-70 Automatic Blood Pressure Monitor
Company
A.M.G. Médicale Inc
Model
107-930
Catalog number
107-930
Device description
This fully automatic BP monitor for home use is designed with an extra large easy to read screen and offers multi user features for 2 people. The Avantia BPM-70 Automatic Blood Pressure Monitor includes a universal size arm cuff to accommodate a circumference of approximately 8.7” - 16.5” / 22 cm - 42 cm and features a heart rate indicator and date & time indicator.Large screenDual-user (2 x 60 memories)Heart rate indicatorHypertension risk indicatorDate and time indicatorAM / PM averagingUniversal cuff included
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00057565975304PackageGS124In Commercial Distribution
00775757079301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00057565975304000575659753040575659753040057565975304
00775757079301007757570793017757570793010775757079301

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-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 not designed to be portable and is typically used bedside.

Regulatory Flags#

DUNS number
207372814
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00057565166184PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, Oral (Blue)016-618016-6182023-06-09
00057565166191PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red)016-619016-6192023-06-09
00057565166283Physio Logic Accuflex Digital Thermometer016-628016-6282023-06-09
00057565166290Physio Logic Accuflex Digital Thermometer - Red016-629016-6292023-06-09
00057565166481ACCUFLEXPRO+ ORAL THERMOMETER (BLUE)016-648016-6482023-06-09
00057565166498ACCUFLEXPRO+ RECTAL THERMOMETER (RED)016-649016-6492023-06-09
00057565964568PhysioLogic DigiPro+ 30 second Digital Oral Thermometer016-625016-6252023-06-09
00775757713175Avantia Ultra-Comfort Commode771-3172020-04-20
00775757713151Avantia Portable Steel Commode771-3152020-04-16
00057565168102FeverScan Fever Indicators by Physio Logic016-800016-8002023-06-13
00057565976042FeverScan Fever Indicators by Physio Logic016-800016-8002023-06-13
00775757154251ProActive Alevia 2 in 1 TENS715-425715-4252023-06-12
00057565975106PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, Oral (Blue)016-618016-6182023-06-09
00057565975120PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red)016-619016-6192023-06-09
00057565972846Physio Logic Accuflex Digital Thermometer016-628016-6282023-06-09
00057565972853Physio Logic Accuflex Digital Thermometer - Red016-629016-6292023-06-09
00057565973447ACCUFLEXPRO+ ORAL THERMOMETER (BLUE)016-648016-6482023-06-09
00057565973461ACCUFLEXPRO+ RECTAL THERMOMETER (RED)016-649016-6492023-06-09
00057565166252PhysioLogic DigiPro+ 30 second Digital Oral Thermometer016-625016-6252023-06-09
00057565975304Avantia BPM-70 Automatic Blood Pressure Monitor107-930107-9302023-06-09

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Primary DI, Brand, Company table
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