ACIST Navvus®II Catheter

GUDID 10841716103244

Navvus II Catheter, p/n 701711-003

ACIST MEDICAL SYSTEMS, INC.

Catheter-tip transducer, pressure

• Primary Device ID: 10841716103244
• NIH Device Record Key: 3a970bc8-faa7-49a8-8311-effb788bbf08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIST Navvus®II Catheter
• Version Model Number: 016675
• Company DUNS: 926684994
• Company Name: ACIST MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841716102483 [Previous]
GS1	10841716103244 [Primary]
GS1	20841716103241 [Package]; Package: Shelf Box [5 Units]; In Commercial Distribution
GS1	30841716103248 [Package]; Contains: 20841716103241; Package: Ship Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190473

FDA Product Code

• OBI: Catheter, Pressure Monitoring, Cardiac

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: 2025-01-28
• Device Publish Date: 2025-01-20

Devices Manufactured by ACIST MEDICAL SYSTEMS, INC.

• 10841716101875 - ACIST CVi® Contrast Delivery System Injector Head: 2025-12-08 CVi Injector, p/n 700706-010
• 10841716101882 - ACIST CVi® Contrast Delivery System Injector Head: 2025-12-08 CVi Injector (Siemens), p/n 700708-010
• 10841716101899 - ACIST CVi® Contrast Delivery System Control Panel: 2025-12-08 ACIST CVi® Contrast Delivery System Control Panel, p/n 701557-002
• 10841716101905 - ACIST CVi® Contrast Delivery System Power Supply: 2025-12-08 CVi Power Supply p/n 701340-003
• 10841716103480 - CT Exprès Patient Set: 2025-08-25 CT Exprès Patient Set
• 10841716103602 - ACIST Kodama® Coronary Imaging Catheter: 2025-08-22 Kodama Catheter, Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag
• 10841716103244 - ACIST Navvus®II Catheter: 2025-01-28Navvus II Catheter, p/n 701711-003
• 10841716103244 - ACIST Navvus®II Catheter: 2025-01-28 Navvus II Catheter, p/n 701711-003
• 10841716103763 - ACIST RXi® Console with dPR: 2025-01-28 RXi Console with dPR, US (p/n: 800939-010 )