BLUE HAND

GUDID 10817625020378

3" round, Foam Top Electrodes, 1 pouch(2 pairs per pouch)

BIOPROTECH INC.

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 10817625020378
• NIH Device Record Key: 6cb843be-41b6-4320-9148-f785e073af39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLUE HAND
• Version Model Number: 03RD FO
• Company DUNS: 688460539
• Company Name: BIOPROTECH 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817625020371 [Primary]
GS1	10817625020378 [Package]; Contains: 00817625020371; Package: Poly Bag [10 Units]; In Commercial Distribution
GS1	20817625020375 [Package]; Package: Inner Box [10 Units]; In Commercial Distribution
GS1	30817625020372 [Package]; Contains: 20817625020375; Package: Carton Box [5 Units]; In Commercial Distribution

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: 2024-12-25
• Device Publish Date: 2024-12-17

On-Brand Devices [BLUE HAND]

• 10817625020415: 1.5" round, Fabric Top Electrodes, 1 pouch(2 pairs per pouch)
• 10817625020385: 1.5"x1.5" sq. 1 pouch(2 pairs per pouch)
• 10817625020378: 3" round, Foam Top Electrodes, 1 pouch(2 pairs per pouch)
• 10817625020361: 3" round, Fabric Top Electrodes, 1 pouch(2 pairs per pouch)
• 10817625020354: 2"x2" sq., Fabric Top Electrodes, 1 pouch(2 pairs per pouch)
• 10817625020347: 1.5" round, Foam Top Electrodes, 1 pouch(2 pairs per pouch)
• 10817625020200: 2"x4" rect., Foam Top Electrodes, 1 pouch(2 pairs per pouch)
• 10817625020194: 2"x4" rect., Fabric Top Electrodes, 1 pouch(2 pairs per pouch)
• 10817625020187: 2"x2" sq., Foam Top Electrodes, 1 pouch(2 pairs per pouch)