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HealthMark TS 350N

by CODAN US Corporation

HealthMark TS 350N is an intravenous fluid bag spike (FDA Class II; FDA product code LHI, Set, I.V. Fluid Transfer) made by CODAN US Corporation, listed in FDA GUDID since 18 Nov 2016 (UDI-DI 10813153023898), 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 Number10813153023898 UDI-DI Date18 Nov 2016ListedStatusListed 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  • Withdrawn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
HealthMark
Generic name
Intravenous fluid bag spike
Model / reference
TS 350N
Primary DI / UDI-DI
10813153023898
FDA product code
LHI
GMDN term
Intravenous fluid bag spike
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intravenous fluid bag spike

Similar devices

Other devices filed under FDA product code LHI (Set, I.V. Fluid Transfer).

Other devices from CODAN US Corporation

See all devices from CODAN US Corporation →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)