SENSINEL™ CPM ALIGNMENT TOOL

Basic Information

• Brand Name: SENSINEL™ CPM ALIGNMENT TOOL
• Primary DI: 00860006382346
• Version / Model: ADCP1100-AT-001
• Company Name: Analog Devices, Inc.
• Labeler DUNS: 001418417
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-13
• Public Version: 1
• Public Version Date: 2025-03-21
• Public Version Status: New
• Public Device Record Key: bc800072-c6d7-4dbc-b137-05f7bc6bfa17

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2
BZQ	Monitor, Breathing Frequency	Anesthesiology	868.2375	2
DPS	Electrocardiograph	Cardiovascular	870.2340	2
DQD	Stethoscope, Electronic	Cardiovascular	870.1875	2
DSB	Plethysmograph, Impedance	Cardiovascular	870.2770	2
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	870.2920	2
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65834	Wearable multiple vital physiological parameter monitoring system	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860006382346	GS1

Premarket Submissions

Submission Number	Supplement Number
K231086	000
K243216	000