Thermodilution Catheter and Accessories 21-000117-11

GUDID 20886333222210

BIOPTIMAL INTERNATIONAL PTE. LTD.

Pulmonary artery catheter, thermal dilution

• Primary Device ID: 20886333222210
• NIH Device Record Key: 448f6dba-97aa-470e-8bb5-269bfb6be0be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermodilution Catheter and Accessories
• Version Model Number: TD1704NDX-ARG(497539)
• Catalog Number: 21-000117-11
• 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

Customer Support Contacts

• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com

Operating and Storage Conditions

• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00886333222216 [Primary]
GS1	20886333222210 [Package]; Contains: 00886333222216; Package: CTN [30 Units]; In Commercial Distribution

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-06-30
• Device Publish Date: 2016-09-01

On-Brand Devices [Thermodilution Catheter and Accessories]

• 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)