Dragonfly®

GUDID B006EAKITM1

NEUROVISION MEDICAL PRODUCTS, INC.

Electromyographic endotracheal tube electrode

• Primary Device ID: B006EAKITM1
• NIH Device Record Key: cab756d5-914f-490d-8db0-141495f79fc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dragonfly®
• Version Model Number: N/A
• Company DUNS: 182057401
• Company Name: NEUROVISION MEDICAL PRODUCTS, INC.
• Device Count: 5
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	B006EAKITM1 [Unit of Use]
HIBCC	B006EAKITM52 [Primary]
HIBCC	EAKITM5 [Package]; Contains: B006EAKITM52; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003745

FDA Product Code

• ETN: Stimulator, Nerve

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-28
• Device Publish Date: 2023-03-20

On-Brand Devices [Dragonfly®]

• B006DCKITLT1: N/A
• DCKITLD5: N/A
• B006LTE7003PLD1: N/A
• B006EAKITMT1: N/A
• B006EAKITMSPD1: N/A
• B006EAKITMSP1: N/A
• B006EAKITMD1: N/A
• B006EAKITM1: N/A
• B006DCKITST1: N/A
• B006DCKITSD1: N/A
• SCKITMT5: N/A
• SCKITMST5: N/A
• SCKITMSD5: N/A
• SCKITMS5: N/A
• SCKITMD5: N/A
• SCKITM5: N/A