FDA.reportPublic FDA data

ABPM pro basic device

Primary DI
04250413405640
Brand
ABPM pro basic device
Company
SOMNOmedics AG
Model
ABP050U
Published
2024-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DSHRecorder, Magnetic Tape, Medical
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231104000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231104000ABPMproSomnomedics GmbH2023-11-27DSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250413405640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250413405640042504134056404250413405640

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient (typically on the arm or wrist) during daily activities for 24-hour recording of blood pressure; it is not intended to detect cardiac arrythmias. The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. The device typically incorporates display and controls and may include a cuff with connection tubing and/or calibration device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314112173
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250413402748SOMNOwatch plus ACTISOWP100Z2023-12-07
04250413402755SOMNOwatch plus ACTISOWP200Z2023-12-07
04250413401475SOMNOwatch plus ACTISOWP2002019-04-12
04250413401666SOMNOwatch plus Docking StationSOW1062019-04-12
04250413410705Set for wireless PLM measurementNGA1132019-08-13
042504134107121 channel ECG sensor including body position and disposable electrodesNGS091S2019-08-13
04250413410781SOMNO HD / ECO accessoryNGA3102023-11-30
04250413410828SOMNOscreen ECO EEG 32NGN740U 2023-11-30
04250413410835SOMNOtouch RESP accessoryTOS110S2023-11-30
04250413410842SOMNOtouch RESP accessoryTOS175S2023-11-30
04250413410859SOMNOtouch RESP accessoryTOS011S2023-11-30
04250413400522SOMNOscreen Plus accessorySEN614O2023-08-25
04250413400607SOMNOscreen Plus accessorySEN6132023-08-25
04250413400614SOMNOscreen Plus accessorySEN6142023-08-25
00833166000405SOMNOscreen plus AccessorySEN2092017-05-22
00833166000412SOMNOscreen plus AccessorySEN2152017-05-22
04250413400362Microphone for Snoring detectionSEN6022019-04-12
04250413400386Activity Sensor for Sleep/Wake detectionSEN6202019-04-12
042504134004161-channel ECG ElectrodeSEN6272019-04-12
04250413400461Effort Sensor SEN6402019-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911225AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911232AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
06976528061608Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06976528061615Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06932825303216TeleRPMGuangdong Transtek Medical Electronics Co.,LtdDXN2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2026-06-02
06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
06976528060335Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060342Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060359Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060366Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060373Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060380Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
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B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27