FDA.reportPublic FDA data

BP-BT Lifeprobes Kiosk

Primary DI
B322E0011
Brand
BP-BT Lifeprobes Kiosk
Company
LD TECHNOLOGY, LLC
Model
E001
Device description
"""BP-BT Kiosk is designed to measure blood pressure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 6.7 inches (17.0 cm) to 16.5 inches (42.0 cm). Indication : Prescription use in medical or clinic environment only. Rx only."""
Published
2024-03-05
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200287000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200287000BP-BT KioskLd Technology, LLC2020-05-15DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B322E0011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a manually-inflated cuff that typically fits around a limb (arm or thigh). 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
305-379-9900albert.ldteck@gmail.com

Regulatory Flags#

DUNS number
079443785
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B322H0011LD-EKGH0012024-03-05
B322A0011SweatCA0012019-03-12
B322B0011TM-Oxi SystemB0012019-01-16
B322F0011ES-BC F0012024-03-05
B322G0011ANS1 SoftwareG0012024-03-05
B322C0011TBL-ABIC0012019-01-16
B322D0011LD-OxyD0012019-01-16

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