FDA.reportPublic FDA data

Clovis AI RPM

Primary DI
00850047516046
Brand
Clovis AI RPM
Company
Remote Smart Health, LLC
Model
12913
Device description
Blood Pressure with Micro Aircuff Watch-4G Cellular
Published
2026-05-26
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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182018000Bluetooth blood pressure monitorShenzhen Kingyield Technology Co., Ltd.2018-10-06DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047516046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047516046008500475160468500475160460850047516046

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.

Regulatory Flags#

DUNS number
093676659
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850047516043Clovis AI RPM129132026-05-26
00850047516039KismeTruth Remote Patient Monitoring101092026-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850047516043Clovis AI RPMRemote Smart Health, LLCDXN2026-05-26
06920485308412PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-05-23
16942284601461SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601482SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601499SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601505SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601512SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601529SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601864SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
16942284601874SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
16942284601881SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601895SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
16942284601904SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601987SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
06951727602906MBUPAIShenzhen Changkun Technology Co., Ltd.DXN2026-03-24
26970392218445SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
06975164324436HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324535HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324542HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324610HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324627HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
00816042016356FORAFORA CARE INC.DXN2026-03-20
06953205995074Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995081Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995098Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995104Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995111Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995128Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995135Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995142Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20