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FlowKeepers EP-201 Pro Bundle

by Krenerb, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00860012717637 UDI-DI Date14 Nov 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
FlowKeepers
Generic Name
Electrode conductive skin pad, reusable
Model / Reference
EP-201 Pro Bundle
Primary DI / UDI-DI
00860012717637
FDA Product Code
GXY, NGX, NUH
GMDN Term
Electrode conductive skin pad, reusable
Device Class
Class II
Regulation Number
882.1320, 890.5850, 882.5890
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Krenerb, LLC

Properties

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

Other properties (10)

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