UE BioSleeve 33

GUDID B3673350

Cutaneous Electrode Garment Released as revision 5 on 2017-11-28

AXIOBIONICS

Transcutaneous electrical stimulation electrode

• Primary Device ID: B3673350
• NIH Device Record Key: 527226de-55cf-48cf-b172-9e585861af7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UE BioSleeve
• Version Model Number: 5
• Catalog Number: 33
• 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	B3673340 [Previous]
HIBCC	B3673350 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-18
• Device Publish Date: 2021-01-08

On-Brand Devices [UE BioSleeve]

• B3673600: Cutaneous Electrode Garment
• B367360: Cutaneous Electrode Garment
• B3673500: Cutaneous Electrode Garment
• B3673440: Cutaneous Electrode Garment
• B3673340: Cutaneous Electrode Garment
• B3673240: Cutaneous Electrode Garment
• B3673140: Cutaneous Electrode Garment
• B3673010: Cutaneous Electrode Garment
• B3673350: Cutaneous Electrode Garment Released as revision 5 on 2017-11-28