Home GUDID 20886333222227 Thermodilution Catheter and Accessories
Primary DI 20886333222227
Brand Thermodilution Catheter and Accessories
Company BIOPTIMAL INTERNATIONAL PTE. LTD.
Model CL1702NX-ARG(497540)
Catalog number 21-000148-02
Published 2016-09-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
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 20886333222227 Package GS1 30 In Commercial Distribution 00886333222223 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20886333222227 20886333222227 00886333222223 00886333222223 886333222223 0886333222223
GMDN Terms# Term, Definition table Term Definition Pulmonary artery catheter, standard A flexible tube with an inflatable balloon at its distal tip designed to be introduced percutaneously into the venous system via a central vein (e.g., jugular, subclavian) and advanced from the superior vena cava to the pulmonary artery, to measure/monitor a haematological parameter(s) (e.g., pulmonary arterial pressures, continuous cardiac output, stroke volume) via the pressure changes at its distal tip; it is not intended to be used for thermal dilution techniques. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., external blood pressure transducer) and may include devices dedicated to introduction. 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
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 false 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
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