ACIST Navvus® Catheter

GUDID 20841716100004

Navvus Catheter, p/n 701481-002

ACIST MEDICAL SYSTEMS, INC.

Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure

• Primary Device ID: 20841716100004
• NIH Device Record Key: e2e0f12d-91ba-47eb-b1af-9177b9662fa6
• Commercial Distribution Discontinuation: 2019-04-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ACIST Navvus® Catheter
• Version Model Number: 014667
• Company DUNS: 926684994
• Company Name: ACIST MEDICAL SYSTEMS, INC.
• 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: false
• 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

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	10841716100007 [Primary]
GS1	20841716100004 [Package]; Contains: 10841716100007; Package: Inner box [5 Units]; Discontinued: 2019-04-10; Not in Commercial Distribution
GS1	30841716100650 [Package]; Package: Shelf box [1 Units]; Discontinued: 2019-04-10; Not in Commercial Distribution
GS1	30841716101220 [Package]; Package: Shelf box [1 Units]; Discontinued: 2019-04-10; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132474

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-06-12
• Device Publish Date: 2016-09-09

On-Brand Devices [ACIST Navvus® Catheter]

• 10841716100014: Navvus Catheter, p/n 701481-003
• 20841716100004: Navvus Catheter, p/n 701481-002