FlowKeepers Gel Pads

Basic Information

• Brand Name: FlowKeepers Gel Pads
• Primary DI: 00860012717613
• Version / Model: Gel Pad Envelope
• Company Name: KRENERB
• Labeler DUNS: 144867619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-29
• Public Version: 1
• Public Version Date: 2026-01-06
• Public Version Status: New
• Public Device Record Key: 0fe168ad-6f94-4f4c-af15-83226842ab88

Device Description

Gel pad envelope with 2 packs of 2 gel pads each, Total of 4 gel packs

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65319	Electrode conductive skin pad, reusable	A noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., transcutaneous electrical stimulation electrode) and the skin surface. It is typically in the form of a gel pad/patch designed to adhere the electrode (not included) to the skin surface. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860012717613	GS1
Package	10860012717610	GS1	Box	2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K131720	000

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	2.3	Square centimeter