Skip to content

Igloo Wound Irrigator 5500

by Bionix, LLC

Igloo Wound Irrigator 5500 is a wound irrigation kit (FDA Class I; FDA product code KYZ, Syringe, Irrigating (Non Dental)) made by Bionix, LLC, listed in FDA GUDID since 6 Mar 2017 (UDI-DI 00859911004375), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00859911004375 UDI-DI Date6 Mar 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Igloo Wound Irrigator
Generic name
Wound irrigation kit
Model / Ref / Catalog
5500
Primary DI / UDI-DI
00859911004375
FDA product code
KYZ
GMDN term
Wound irrigation kit
Device class
Class I
Regulation number
880.6960
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wound irrigation kit

Similar devices

Other devices filed under FDA product code KYZ (SYRINGE, IRRIGATING (NON DENTAL)).

Other devices from Bionix, LLC

See all devices from Bionix, LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)