bioptimalg.comSilicone Foley Catheter - FC316S
2026-05-04
Bioptimal International Pte. Ltd.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8043983 | 3016261803 | Bioptimal International Pte. Ltd. | 1 | N | 2026-01-01 | 14 Kaki Bukit View SINGAPORE South East SG 415950 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 08886483500174 | Thermodilution Catheter and Accessories - TD2604NXF | +6568592341 | ra-bpi@bioptimalg.com |
| 08886483500181 | Thermodilution Catheter and Accessories - TD2604NDXF | +6568592341 | ra-bpi@bioptimalg.com |
| 08886483507470 | Silicone Foley Catheter - FC316S | +6568592341 | ra-bpi@bioptimalg.com |
| 08886483507487 | Silicone Foley Catheter - FC314S | +6568592341 | ra-bpi@bioptimalg.com |
| 08886483507494 | Silicone Foley Catheter - FC318S | +6568592341 | ra-bpi@bioptimalg.com |
| 08886483551640 | Thermodilution Catheter and Accessories - TD1755HD | +6568592341 | ra-bpi@bioptimalg.com |
| 08886483551657 | Thermodilution Catheter and Accessories - TD2755NDF | +6568592341 | ra-bpi@bioptimalg.com |
| 08886483551664 | Safewedge(TM) Relief Valve Device - Safetywedge | +6568592341 | ra-bpi@bioptimalg.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 45221 | 1741677834 | K983372 | BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP | DRS | 1999-02-05 |
| 45221 | 1127346914 | K981747 | BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX | DRS | 1998-08-20 |
| 45221 | 1541975350 | K981745 | BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX | DRS | 1998-07-17 |
| 45221 | 1441001417 | K973477 | BIOSENSORS EMBOLECTOMY CATHETER | DXE | 1998-09-04 |
| 45221 | 1095123954 | K912172 | SAFEWEDGE(TM) RELIEF VALVE DEVICE | KRB | 1991-09-27 |
| 45221 | 1355190454 | K911710 | HEPARIN COATED THERMODILUTION CATH & ACCESSORIES | DQO | 1991-10-23 |
| 45221 | 1272027186 | K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N | DQO | 2026-05-28 |
| 45221 | 1846579606 | K242863 | Bioptimal Bipolar Pacing Catheter | LDF | 2025-06-15 |
| 45221 | 1748942436 | K182463 | Silicone Foley Catheter | EZL | 2019-11-06 |
| 45221 | 1751433405 | K101669 | THERMODILUTION CATHETER | DQO | 2010-07-01 |
| 45221 | 1596926331 | K083384 | THERMODILUTION CATHETER | DQO | 2010-01-05 |
| 45221 | 2003364914 | K070710 | ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM | DRS | 2007-04-19 |
| 45221 | 1167180885 | K022004 | CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 | DQO | 2003-03-12 |
| 45221 | 1104421727 | K002786 | BIOSENSORS CENTRAL VENOUS CATHETER KITS | FOZ | 2000-11-17 |
Product Codes Associated With Registrations#
GUDID#
Silicone Foley Catheter - FC314S
2026-05-04
Silicone Foley Catheter - FC318S
2026-05-04
Thermodilution Catheter and Accessories - TD1755HD
2026-05-20
Thermodilution Catheter and Accessories - TD2755NDF
2026-05-20
Safewedge(TM) Relief Valve Device - Safetywedge
2026-05-20
Thermodilution Catheter and Accessories - TD2604NXF
2026-05-04
Thermodilution Catheter and Accessories - TD2604NDXF
2026-05-04
Thermodilution Catheter and Accessories - TD2504NXF
2026-05-04
Thermodilution Catheter and Accessories - TD2504NDXF
2026-05-04
Thermodilution Catheter and Accessories - TD2704NDF
2026-05-04
Thermodilution Catheter and Accessories - TD2704NCXF
2026-05-04
Thermodilution Catheter and Accessories - TD2755NX
2026-05-04
Thermodilution Catheter and Accessories - TD2755NDF
2026-05-04
Thermodilution Catheter and Accessories - TD2755NDX
2026-05-04
Thermodilution Catheter and Accessories - TD2755NDPXF
2026-05-04
BIOTRANS™ Pressure Monitoring Kits - BTR4812-3
2026-05-04
BIOTRANS™ Pressure Monitoring Kits - EXTENSION TUBING SET
2026-05-04
ACCUTRANS Disposable Pressure Monitoring Kit - AT W/O IFU(BNS)
2026-05-04
Embolectomy Catheter - EL1440
2026-05-04
Embolectomy Catheter - EL1580
2026-05-04
Embolectomy Catheter - EL1540
2026-05-04
BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables - BT-201
2026-05-04
Bipolar Pacing Catheter - BP2502-10
2026-05-04
Central Venous Catheter Kit - CV-713-16
2026-05-04
Biosensors Central Venous Catheter Kit - CVR-501-16
2016-09-01
Thermodilution Catheter and Accessories - TD1602NX-ARG(497527)
2016-09-01
Thermodilution Catheter and Accessories - TD2602NXF-MERIT(EUROPE)
2023-10-31
Thermodilution Catheter and Accessories - TD1702NX-ARG(497523)
2020-10-01
Thermodilution Catheter and Accessories - TD1602NX-ARG(497527)
2020-10-01
Thermodilution Catheter and Accessories - CL1702NX-ARG(497540)
2020-10-01
ACCUTRANS™ Disposable Pressure Monitoring System - AT 4812-3
2025-01-22
Thermodilution Catheter and Accessories - TD2755NDFX-BSI
2016-09-01
Thermodilution Catheter and Accessories - TD2704NFX (BNS) - CMS USA
2016-09-01
Thermodilution Catheter and Accessories - TD2704NCFX-BSI
2016-09-01
Inline Sensor Assembly and Inline Temperature Sensor - INLINE TEMPERATURE SENSOR (ILS-1)
2016-09-01
Thermodilution Catheter and Accessories - TD2755NX-CCF
2016-09-01
Thermodilution Catheter and Accessories - TD2604NX (BNS)-CMS USA
2016-08-24
Thermodilution Catheter and Accessories - TD2704NXF-BSI
2016-09-01
Thermodilution Catheter and Accessories - TD1755ND-ARG(497520)
2016-09-01