Home GUDID 98888893204751 Thermodilution Catheter and Accessories
Primary DI 98888893204751
Brand Thermodilution Catheter and Accessories
Company BIOPTIMAL INTERNATIONAL PTE. LTD.
Model TD2604NX (BNS)-CMS USA
Catalog number 21-000009-41
Published 2016-08-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name DQO Catheter, Intravascular, Diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQO Catheter, Intravascular, Diagnostic Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 38888893204759 Package GS1 50 In Commercial Distribution 98888893204751 Package GS1 9 In Commercial Distribution 08888893204758 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 38888893204759 38888893204759 98888893204751 98888893204751 08888893204758 08888893204758 8888893204758
GMDN Terms# Term, Definition table Term Definition Pulmonary artery catheter, thermal dilution A flexible tube with an inflatable balloon at its distal tip designed to be introduced percutaneously into the venous system via a central vein and advanced to the pulmonary artery, to measure/monitor haematological parameters (e.g., pulmonary arterial pressures, intermittent cardiac output, cardiac index) using thermal dilution techniques; it may also be intended for venous blood sampling. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., blood pressure transducer) [not included], and includes an exit port for the solution and an electrical component (e.g., thermistor) for temperature measurements. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in dark cool dry places
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 595182247 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08886483551640 Thermodilution Catheter and Accessories TD1755HD 21-000153-50 2026-05-20 08886483551657 Thermodilution Catheter and Accessories TD2755NDF 21-000202-45 2026-05-20 08886483551664 Safewedge(TM) Relief Valve Device Safetywedge 21-000212-01 2026-05-20 08886483500174 Thermodilution Catheter and Accessories TD2604NXF 21-000009-58 2026-05-04 08886483500181 Thermodilution Catheter and Accessories TD2604NDXF 21-000009-59 2026-05-04 08886483500372 Thermodilution Catheter and Accessories TD2504NXF 21-000046-43 2026-05-04 08886483500389 Thermodilution Catheter and Accessories TD2504NDXF 21-000046-44 2026-05-04 08886483501508 Thermodilution Catheter and Accessories TD2704NDF 21-000201-16 2026-05-04 08886483501515 Thermodilution Catheter and Accessories TD2704NCXF 21-000201-17 2026-05-04 08886483501546 Thermodilution Catheter and Accessories TD2755NX 21-000202-00 2026-05-04 08886483501553 Thermodilution Catheter and Accessories TD2755NDF 21-000202-01 2026-05-04 08886483501577 Thermodilution Catheter and Accessories TD2755NDX 21-000202-03 2026-05-04 08886483501584 Thermodilution Catheter and Accessories TD2755NDPXF 21-000202-04 2026-05-04 08886483502390 BIOTRANS™ Pressure Monitoring Kits BTR4812-3 22-000813-23 2026-05-04 08886483503151 BIOTRANS™ Pressure Monitoring Kits EXTENSION TUBING SET 22-000895-96 2026-05-04 08886483503748 ACCUTRANS Disposable Pressure Monitoring Kit AT W/O IFU(BNS) 22-000940-02 2026-05-04 08886483504455 Embolectomy Catheter EL1440 23-000006-15 2026-05-04 08886483504486 Embolectomy Catheter EL1580 23-000006-18 2026-05-04 08886483504516 Embolectomy Catheter EL1540 23-000006-21 2026-05-04 08886483507005 BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables BT-201 BL-0003-018 2026-05-04
Other Devices Sharing Product Codes# 
biosensors.com