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FlowKeepers Gel Pads Gel Pad Envelope

by Krenerb, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860012717613 UDI-DI Date29 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
FlowKeepers Gel Pads
Generic Name
Electrode conductive skin pad, reusable
Model / Reference
Gel Pad Envelope
Primary DI / UDI-DI
00860012717613
510(k) Number
FDA Product Code
GXY
GMDN Term
Electrode conductive skin pad, reusable
Device Class
Class II
Regulation Number
882.1320
GUDID distribution status
In Commercial Distribution
Size
Area/Surface Area — 2.3 Square centimeter

Other devices from Krenerb, LLC

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No