ACCUTRANS™ Disposable Pressure Monitoring System 22-000942-03

GUDID 08886483503854

BIOPTIMAL INTERNATIONAL PTE. LTD.

Invasive blood pressure transducer set

• Primary Device ID: 08886483503854
• NIH Device Record Key: 6c2276bb-0dbc-490c-98e2-d398e609b6ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCUTRANS™ Disposable Pressure Monitoring System
• Version Model Number: AT 4812-3
• Catalog Number: 22-000942-03
• Company DUNS: 595182247
• Company Name: BIOPTIMAL INTERNATIONAL PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08886483503854 [Primary]

FDA Product Code

• DRS: Transducer, Blood-Pressure, Extravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-30
• Device Publish Date: 2025-01-22

Devices Manufactured by BIOPTIMAL INTERNATIONAL PTE. LTD.

• 08886483503854 - ACCUTRANS™ Disposable Pressure Monitoring System: 2025-01-30
• 08886483503854 - ACCUTRANS™ Disposable Pressure Monitoring System: 2025-01-30
• 08886483501492 - Thermodilution Catheter and Accessories: 2023-11-13
• 08886483501393 - Thermodilution Catheter and Accessories: 2023-11-08
• 08886483501560 - Thermodilution Catheter and Accessories: 2023-11-08
• 08886483501829 - BIOTRANS™ Pressure Monitoring Kits: 2023-11-08
• 08886483502949 - BIOTRANS™ Pressure Monitoring Kits: 2023-11-08
• 08886483505636 - Central Venous Catheter Kit: 2023-11-08
• 08886483506008 - Central Venous Catheter Kit: 2023-11-08