FDA.report

Thermodilution Catheter and Accessories

Primary DI
08886483501560
Company
BIOPTIMAL INTERNATIONAL PTE. LTD.
Model
TD2755NXF-MERIT(EUROPE)
Catalog number
21-000202-02
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
08886483501560PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
08886483501560PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
DQOCatheter, Intravascular, Diagnostic2Cardiovascular870.1200NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Pulmonary artery balloon catheter, thermal dilutionA 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.

Device Sizes

No records found.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark cool dry places

Sterilization Methods

Method

Contacts

No records found.

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08886483501393Thermodilution Catheter and AccessoriesTD2602NXF-MERIT(EUROPE)21-000151-122023-10-31
08886483501829BIOTRANS™ Pressure Monitoring KitsPT24(BNS)-USA22-000074-102023-10-31
08886483502949BIOTRANS™ Pressure Monitoring KitsMED-LOC LOCKING CANNULA-USA22-000895-552023-10-31
08886483505636Central Venous Catheter KitCV-501-1625-000009-032023-10-31
08886483506008Central Venous Catheter KitCV-802-2025-000017-012023-10-31
08886483507524Embolectomy CatheterEL3340EC-0001-0032023-10-31
08886483508859Central Venous Catheter KitCV-713-16T24-000251-032023-10-31
08886483504257ACCUTRANS Disposable Pressure Monitoring KitAT 4812-3 - 22-000948-2122-000948-212021-05-06
08886483508323BIOTRANS™ Pressure Monitoring KitsBTR-4812-3 (CAT#5510219)-GE22-000813-302021-03-23
08886483508330BIOTRANS™ Reusable Sensor Base and Monitor Adapter CablesBT-201 (CAT#5867983)-GEBL-0003-0212021-03-23
08886483500099Thermodilution Catheter and AccessoriesTD2604NX (BNS)-CMS USA21-000009-412020-10-01
08886483500525Thermodilution Catheter and AccessoriesTD2704NXF-BSI21-000048-772020-10-01
08886483500686Thermodilution Catheter and AccessoriesTD2755NX-CCF21-000050-702020-10-01
08886483500761Thermodilution Catheter and AccessoriesTD2755NDFX-BSI21-000050-922020-10-01
08886483501232Thermodilution Catheter and AccessoriesTD1755ND-ARG(497520)21-000116-082020-10-01
08886483501249Thermodilution Catheter and AccessoriesTD1755NSD-ARG(497531)21-000116-092020-10-01
08886483501256Thermodilution Catheter and AccessoriesTD1704ND-ARG(497521)21-000117-072020-10-01
08886483501263Thermodilution Catheter and AccessoriesTD1704NX-ARG(497526)21-000117-082020-10-01

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