FDA.reportPublic FDA data

Pulsewave Blood Pressure Monitor

Primary DI
00867661000318
Brand
Pulsewave Blood Pressure Monitor
Company
CLOUD DX INC.
Model
PAD-1A
Published
2019-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K122443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122443000UFIT TEN-10Biosign Technologies, Inc.2012-11-20DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867661000318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867661000318008676610003188676610003180867661000318

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-543-0944regulatory@clouddx.com

Regulatory Flags#

DUNS number
079659378
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00867661000370Wireless Infrared ThermometerWIT-102022-05-10
00867661000356Wireless Pulse OximeterWPO-10B2020-06-05
00867661000349Wireless Pulse OximeterWPO-102019-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06953825911225AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911232AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
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08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2026-06-02
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06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
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