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Sdfix 01

by Dfix

Sdfix 01 is a wearable percutaneous catheter/tube holder (FDA Class I; FDA product code KMK, Device, Intravascular Catheter Securement) made by Dfix, listed in FDA GUDID since 27 Jan 2023 (UDI-DI 08800125000006), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800125000006 UDI-DI Date27 Jan 2023ListedStatusListed 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  • Withdrawn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
Sdfix
Generic name
Wearable percutaneous catheter/tube holder, single-use
Model / reference
01
Primary DI / UDI-DI
08800125000006
FDA product code
KMK
GMDN term
Wearable percutaneous catheter/tube holder, single-use
Device class
Class I
Regulation number
880.5210
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wearable percutaneous catheter/tube holder

Similar devices in this category

Other devices filed under Wearable percutaneous catheter/tube holder.

Other devices from Dfix

See all devices from Dfix →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Manufacturing date
Other properties (11, all answered No)