UE BioSleeve 33

GUDID B3673350

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

AXIOBIONICS

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• 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