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Firefly UV Disinfection Device 40406

by Puracath Medical, Inc

Listed FDA GUDID listing, not in commercial distribution

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 Number00865349000308 UDI-DI Date21 Nov 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Firefly UV Disinfection Device
Generic Name
Peritoneal dialysis system irradiation unit
Model / Reference
40406
Primary DI / UDI-DI
00865349000308
FDA Product Code
KDJ
GMDN Term
Peritoneal dialysis system irradiation unit
Device Class
Class II
Regulation Number
876.5630
GUDID distribution status
Not in Commercial Distribution

Other devices from Puracath Medical, Inc

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No