ADVANCED PATIENT MONITOR

GUDID B510PM2000XLPRO1

ADVANCED INSTRUMENTATIONS, INC.

Transportable physiologic monitoring system

• Primary Device ID: B510PM2000XLPRO1
• NIH Device Record Key: 6794bff1-c7ff-4d1d-9294-7bd6bd318949
• Commercial Distribution Discontinuation: 2028-04-15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVANCED PATIENT MONITOR
• Version Model Number: PM-2000XL PRO
• Company DUNS: 608736880
• Company Name: ADVANCED INSTRUMENTATIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B510PM2000XLPRO1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120631

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-24
• Device Publish Date: 2020-04-16

On-Brand Devices [ADVANCED PATIENT MONITOR]

• B510PM200M1: PM-200M
• B510PM2000XLPRO1: PM-2000XL PRO
• B510PM2000XLPLUS1: PM-2000XL PLUS
• B510PM2000XL1: PM-2000XL
• B510PM2000TM1: PM-2000TM
• B510PM2000M1: PM-2000M
• B510PM2000APRO1: PM-2000A PRO
• B510PM2000A1: PM-2000A