AccessGUDID - DEVICE: SENSINEL™ CPM ALIGNMENT TOOL (00860006382346)

GUDID

Device Identifier (DI) Information

Brand Name: SENSINEL™ CPM ALIGNMENT TOOL
Version or Model: ADCP1100-AT-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Analog Devices, Inc.

Primary DI Number: 00860006382346
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001418417 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
BZQ	Monitor, Breathing Frequency
DPS	Electrocardiograph
DQD	Stethoscope, Electronic
DSB	Plethysmograph, Impedance
DXH	Transmitters And Receivers, Electrocardiograph, Telephone
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231086	000
K243216	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bc800072-c6d7-4dbc-b137-05f7bc6bfa17
Public Version Date: March 21, 2025
Public Version Number: 1
DI Record Publish Date: March 13, 2025