FDA.reportPublic FDA data

SENSINEL™ CPM ALIGNMENT TOOL

Primary DI
00860006382346
Brand
SENSINEL™ CPM ALIGNMENT TOOL
Company
Analog Devices, Inc.
Model
ADCP1100-AT-001
Published
2025-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency
DPSElectrocardiograph
DQDStethoscope, Electronic
DSBPlethysmograph, Impedance
DXHTransmitters And Receivers, Electrocardiograph, Telephone
FLLThermometer, Electronic, Clinical
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2
DPSElectrocardiographCardiovascular2
DQDStethoscope, ElectronicCardiovascular2
DSBPlethysmograph, ImpedanceCardiovascular2
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231086000
K243216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231086000CPM SystemAnalog Devices, Inc.2023-12-22MWI
K243216000Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)Analog Devices2024-12-10MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006382346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006382346008600063823468600063823460860006382346

GMDN Terms#

Term, Definition table
TermDefinition
Wearable multiple vital physiological parameter monitoring systemA portable assembly of electrically-powered devices intended to be worn by a patient in a healthcare or homecare setting for intermittent assessment or continuous monitoring, exclusively by a healthcare professional, of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, haemoglobin oxygen saturation (SpO2), haematocrit]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff, skin patch) and processing hardware with dedicated software. It may include a monitoring screen or allow for remote communication with a smart device or central database.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001418417
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850086928008SENSINEL™ CPM BASE STATIONADCP1100-BS-0022026-06-03
00850086928015SENSINEL™ CPM WEARABLEADCP1100-WB-0022026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)ADCP1100-KIT-ATT2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)ADCP1100-KIT-WHT2026-06-03
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADADI-CS-200-0012025-03-13
00860006382315SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)ADCP1100-PL-0012025-03-13
00860006382322SENSINEL™ CPM WEARABLEADCP1100-WB-0012025-03-13
00860006382339SENSINEL™ CPM BASE STATIONADCP-1100-BS-0012025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)ADI-CS-200-SLA-0012025-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719327007136FinapresFinapres Medical Systems B.V.DSB2026-10-21
09120095900809SteadyTempSteadySense GmbHFLL2026-10-21
00860011800613CardioTagCARDIOSENSE, INC.DPS2026-10-14
00195278840202MACGe Medical Systems Information Technologies, Inc.DPS2026-10-13
06973660370001MinttiSuzhou Melodicare Medical Technology Co., Ltd.DQD2026-10-10
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyFLL2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDPS2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyBZQ2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyFLL2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDPS2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyBZQ2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDPS2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyBZQ2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDPS2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyBZQ2026-10-04
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DPS2026-10-01
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DQD2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DQD2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DPS2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DPS2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DQD2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DPS2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DQD2026-10-01
00810209880217CORE 300™ Digital Stethoscope - BlackEko Health, Inc.DQD2026-10-01
00810209880224CORE 300™ Digital Stethoscope - BerryEko Health, Inc.DQD2026-10-01
00810209880231CORE 300™ Digital Stethoscope - SunsetEko Health, Inc.DQD2026-10-01
00810209880248CORE 300™ Digital Stethoscope - PacificEko Health, Inc.DQD2026-10-01