BioVest 02

GUDID B3670210

Cutaneous Electrode Garment

AXIOBIONICS

Transcutaneous electrical stimulation electrode

• Primary Device ID: B3670210
• NIH Device Record Key: ea8aab5c-233f-40f6-88c6-9677fd6ff100
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioVest
• Version Model Number: 1
• Catalog Number: 02
• Company DUNS: 033139835
• Company Name: AXIOBIONICS
• 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: 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
HIBCC	B3670210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141342

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2016-09-24

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• B36711008L00 - EMPI 300PV Stimulator: 2019-10-23 Neuromuscular Stimulator
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• B36712159L00 - OOFS Pace XL Stimulator: 2019-10-23 Neuromuscular Stimulator
• B367145M00 - Spectra 360 Electrode Gel: 2018-10-22 Electrode Gel Monthly Supply (4 8 oz tubes)