Skip to content

Thermodilution Catheter and Accessories TD2504NXF

by Bioptimal International Pte. Ltd.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08886483500372 UDI-DI Date4 May 2026ListedStatusListed 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  • Withdrawn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
Thermodilution Catheter and Accessories
Generic Name
Pulmonary artery balloon catheter, electrical
Model / Ref / Catalog
TD2504NXF, 21-000046-43
Primary DI / UDI-DI
08886483500372
FDA Product Code
DQO
GMDN Term
Pulmonary artery balloon catheter, electrical
Device Class
Class II
Regulation Number
870.1200
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Bioptimal International Pte. Ltd.

See all devices from Bioptimal International Pte. Ltd. →

Properties

  • Sterile
  • Single Use
  • Contains Latex
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No