AccessGUDID - DEVICE: ADVANCED PATIENT MONITOR (B510PMMAX13)

GUDID

Device Identifier (DI) Information

Brand Name: ADVANCED PATIENT MONITOR
Version or Model: PM-Max13
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADVANCED INSTRUMENTATIONS, INC.

Primary DI Number: B510PMMAX13
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 608736880 *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):	No
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?
36872	Multiple vital physiological parameter monitoring system, clinical	An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
DQA	Oximeter
FLL	Thermometer, Electronic, Clinical
DXN	System, Measurement, Blood-Pressure, Non-Invasive
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
MLD	Monitor, St Segment With Alarm
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
DSI	Detector And Alarm, Arrhythmia
DSK	Computer, Blood-Pressure
DSF	Recorder, Paper Chart
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 43cd78db-9c8a-4c77-b55c-41acf48cb2ca
Public Version Date: December 27, 2024
Public Version Number: 1
DI Record Publish Date: December 19, 2024