FDA.report

ByFloProducts

Primary DI
00628693098151
Brand
ByFloProducts
Company
ByFlo LLC
Model
FC-BP120
Device description
Blood Pressure Monitors
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications

CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10628693098158PackageGS130In Commercial Distribution
00628693098151PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
141150312
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
00628693098144ByFloProductsJZK-6012026-02-18
00628693098175ByFloProductsAOJ-30F2025-12-19

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