Bagnoli-4 EMG System

GUDID 00851679007001

Biofeedback Device

DELSYS, INC.

Biofeedback system

• Primary Device ID: 00851679007001
• NIH Device Record Key: 898f39d0-fcb5-48a0-b478-865cff924dca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bagnoli-4 EMG System
• Version Model Number: DS-B02
• Company DUNS: 826428344
• Company Name: DELSYS, 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: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851679007001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981934

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

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