B&L Engineering Active Surface EMG Electrode

GUDID 00855144007060

Active Surface EMG Electrode Wide Spaced - Ground

PINSCO, INC.

Electromyographic signal amplifier

• Primary Device ID: 00855144007060
• NIH Device Record Key: de308c9a-bb62-4dd9-9d6f-cad091a2d216
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B&L Engineering Active Surface EMG Electrode
• Version Model Number: BL-AE-W/G
• Company DUNS: 079605952
• Company Name: PINSCO, 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: true
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 714-505-9492
• Email: sales@bleng.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855144007060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952655

FDA Product Code

• IKN: Electromyograph, Diagnostic

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: 2017-05-02

On-Brand Devices [B&L Engineering Active Surface EMG Electrode]

• 00855144007077: Active Surface EMG Electrode with Snap
• 00855144007060: Active Surface EMG Electrode Wide Spaced - Ground
• 00855144007053: Active Surface EMG Electrode Wide Spaced - No Ground