ADVANCED MONITOR DEFIBRILLATOR

GUDID B510D100

ADVANCED INSTRUMENTATIONS, INC.

Troponin T IVD, kit, rapid ICT, clinical

• Primary Device ID: B510D100
• NIH Device Record Key: a08a9f8f-fdc3-4f55-a52c-5984d7f73baa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVANCED MONITOR DEFIBRILLATOR
• Version Model Number: D100+
• Company DUNS: 608736880
• Company Name: ADVANCED INSTRUMENTATIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	B510D100 [Primary]

FDA Product Code

• LDD: Dc-Defibrillator, Low-Energy, (Including Paddles)

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: 2026-01-22
• Device Publish Date: 2026-01-14

Devices Manufactured by ADVANCED INSTRUMENTATIONS, INC.

• B510D100 - ADVANCED MONITOR DEFIBRILLATOR: 2026-01-22
• B510D100 - ADVANCED MONITOR DEFIBRILLATOR: 2026-01-22
• B510PT3000 - ADVANCED PHOTOTHERAPY LAMP: 2025-08-29
• B510PM200MPRO1 - ADVANCED PATIENT MONITOR: 2025-07-31
• B510V1000 - ADVANCED VENTILATOR: 2025-02-18
• B510A31860 - ADVANCED NEONATAL INCUBATOR: 2025-02-17
• B510A31861 - ADVANCED NEONATAL INCUBATOR: 2025-02-17
• B510A4051 - ADVANCED INFANT WARMER: 2025-02-17
• B510AM60001 - ADVANCED GAS-MACHINE ANESTHESIA: 2025-02-17