ADVANCED POCKET DOPPLER

GUDID B510PD1000PRO1

ADVANCED INSTRUMENTATIONS, INC.

Foetal Doppler system

• Primary Device ID: B510PD1000PRO1
• NIH Device Record Key: 92b19d5d-85ba-4724-9aa1-6d8737303ba5
• Commercial Distribution Discontinuation: 2028-04-15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVANCED POCKET DOPPLER
• Version Model Number: PD-1000 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	B510PD1000PRO1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111934

FDA Product Code

• HEP: Monitor, Blood-Flow, Ultrasonic

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

On-Brand Devices [ADVANCED POCKET DOPPLER]

• B510PD100PRO1: PD-100 PRO
• B510PD1000PRO1: PD-1000 PRO