FDA.reportPublic FDA data

SENSINEL™ CPM BASE STATION

Primary DI
00850086928008
Brand
SENSINEL™ CPM BASE STATION
Company
Analog Devices, Inc.
Model
ADCP1100-BS-002
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850086928008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850086928008008500869280088500869280080850086928008

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
001418417
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
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
00860006382346SENSINEL™ CPM ALIGNMENT TOOLADCP1100-AT-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
00860016681507UNIVERHEALTHHangzhou Universal Electronic Co.,Ltd.FLL2026-10-28
04719872982296QT ECGQt Medical, Inc.DPS2026-10-28
04719872982302QT ECGQt Medical, Inc.DPS2026-10-28
08800159500060S-Patch CardioAIWellysis Corp.DPS2026-10-27
076401218816261ST272-100 LuMon™ Belt Size 19SenTec AGBZQ2026-10-26
076401218816331ST273-100 LuMon™ Belt Size 22SenTec AGBZQ2026-10-26
076401218816401ST274-100 LuMon™ Belt Size 26SenTec AGBZQ2026-10-26
076401218816571ST275-100 LuMon™ Belt Size 30SenTec AGBZQ2026-10-26
076401218816641ST276-100 LuMon™ Belt Size 35SenTec AGBZQ2026-10-26
076401218816711ST277-100 LuMon™ Belt Size 40SenTec AGBZQ2026-10-26
076401218816881ST278-100 LuMon™ Belt Size 47SenTec AGBZQ2026-10-26
076401218816951ST282-100 LuMon™ Belt Size 80SenTec AGBZQ2026-10-26
076401218817011ST283-100 LuMon™ Belt Size 92SenTec AGBZQ2026-10-26
076401218817181ST284-100 LuMon™ Belt Size 104SenTec AGBZQ2026-10-26
076401218817251ST285-100 LuMon™ Belt Size 116SenTec AGBZQ2026-10-26
076401218817631ST120-100 LuMon™ Connector 2.0SenTec AGBZQ2026-10-26
B353LP1251E1LifeSignalsLifesignals, Inc.DXH2026-10-26
076401218817562ST200-100 LuMon™ MonitorSenTec AGBZQ2026-10-23
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