| Primary Device ID | 08886483500099 |
| NIH Device Record Key | 4216f606-497c-4cf9-91e9-de2d925f4fea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thermodilution Catheter and Accessories |
| Version Model Number | TD2604NX (BNS)-CMS USA |
| Catalog Number | 21-000009-41 |
| Company DUNS | 595182247 |
| Company Name | BIOPTIMAL INTERNATIONAL PTE. LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08886483500099 [Primary] |
| DQO | Catheter, Intravascular, Diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
[08886483500099]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-09 |
| Device Publish Date | 2020-10-01 |
| 20886333222227 | CL1702NX-ARG(497540) |
| 20886333222210 | TD1704NDX-ARG(497539) |
| 20886333222203 | TD1604ND-ARG(497537) |
| 20886333222197 | TD1704NXC-ARG(497536) |
| 20886333222180 | TD1704NDC-ARG(497534) |
| 20886333222173 | TD1755NSD-ARG(497531) |
| 20886333222166 | TD1602NX-ARG(497527) |
| 20886333222159 | TD1704NX-ARG(497526) |
| 20886333222142 | TD1702NX-ARG(497523) |
| 20886333222135 | TD1704ND-ARG(497521) |
| 20886333222128 | TD1755ND-ARG(497520) |
| 58888893205330 | TD2704NXF-BSI |
| 98888893204751 | TD2604NX (BNS)-CMS USA |
| 58888893204562 | TD2755NX-CCF |
| 58888893013089 | TD2704NCFX-BSI |
| 98888893012974 | TD2704NFX (BNS) - CMS USA |
| 58888893012969 | TD2755NDFX-BSI |
| 08886483501461 | TD2704NCFX-BSI |
| 08886483501447 | TD2704NFX (BNS) - CMS USA |
| 08886483501355 | CL1702NX-ARG(497540) |
| 08886483501348 | TD1604ND-ARG(497537) |
| 08886483501317 | TD1602NX-ARG(497527) |
| 08886483501300 | TD1702NX-ARG(497523) |
| 08886483501294 | TD1704NDX-ARG(497539) |
| 08886483501287 | TD1704NXC-ARG(497536) |
| 08886483501270 | TD1704NDC-ARG(497534) |
| 08886483501263 | TD1704NX-ARG(497526) |
| 08886483501256 | TD1704ND-ARG(497521) |
| 08886483501249 | TD1755NSD-ARG(497531) |
| 08886483501232 | TD1755ND-ARG(497520) |
| 08886483500761 | TD2755NDFX-BSI |
| 08886483500686 | TD2755NX-CCF |
| 08886483500525 | TD2704NXF-BSI |
| 08886483500099 | TD2604NX (BNS)-CMS USA |
| 08886483501560 | TD2755NXF-MERIT(EUROPE) |
| 08886483501393 | TD2602NXF-MERIT(EUROPE) |
| 08886483501492 | TD2704NXF-MERIT(EUROPE) |