ADVANCED DOPPLER

GUDID B510TD50001

ADVANCED INSTRUMENTATIONS, INC.

Foetal Doppler system

• Primary Device ID: B510TD50001
• NIH Device Record Key: 9e86b723-f3ac-48d9-b9c0-b2bc33e7ab87
• Commercial Distribution Discontinuation: 2028-04-15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVANCED DOPPLER
• Version Model Number: TD-5000
• 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	B510TD50001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112529

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

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: 2020-04-27
• Device Publish Date: 2020-04-17

Devices Manufactured by ADVANCED INSTRUMENTATIONS, INC.

• 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
• B510FM9000 - ADVANCED FETAL MONITOR: 2025-02-17
• B510PT2000 - ADVANCED LED PHOTOTHERAPY LAMP: 2025-02-17
• B510PT5000 - ADVANCED LED PHOTOTHERAPY LAMP: 2025-02-17