2" x 2" Rectangle Electrodes EERC200400M

GUDID 00850706007304

BioStim 2" x 2" Rectangle Electrodes - 10 pouches of 4 each

BIOMEDICAL LIFE SYSTEMS, INC.

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 00850706007304
• NIH Device Record Key: 8a45caa8-d64f-46cc-bed6-172b124bd019
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2" x 2" Rectangle Electrodes
• Version Model Number: EERC200400M
• Catalog Number: EERC200400M
• Company DUNS: 116956807
• Company Name: BIOMEDICAL LIFE SYSTEMS, 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850706007304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042301

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2024-08-15
• Device Publish Date: 2024-08-07

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