FlowKeepers

GUDID 00860012717637

FlowKeepers Pro Bundle with two devices and 8 gel pads.

KRENERB

Electrode conductive skin pad, reusable

• Primary Device ID: 00860012717637
• NIH Device Record Key: ea458896-4d95-412b-9cb9-3a47a951df25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlowKeepers
• Version Model Number: EP-201 Pro Bundle
• Company DUNS: 144867619
• Company Name: KRENERB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 3023885016
• Email: info@flowkeepers.com
• Phone: 3023885016
• Email: info@flowkeepers.com
• Phone: 3023885016
• Email: info@flowkeepers.com
• Phone: 3023885016
• Email: info@flowkeepers.com
• Phone: 3023885016
• Email: info@flowkeepers.com
• Phone: 3023885016
• Email: info@flowkeepers.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012717637 [Primary]

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: 2025-11-24
• Device Publish Date: 2025-11-14

Devices Manufactured by KRENERB

• 00860012717613 - FlowKeepers Gel Pads: 2026-01-06 Gel pad envelope with 2 packs of 2 gel pads each, Total of 4 gel packs
• 00860012717637 - FlowKeepers: 2025-11-24FlowKeepers Pro Bundle with two devices and 8 gel pads.
• 00860012717637 - FlowKeepers: 2025-11-24 FlowKeepers Pro Bundle with two devices and 8 gel pads.