ACIST Kodama® Coronary Imaging Catheter

GUDID 10841716100755

Kodama Catheter, p/n 701470-001 Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag, IFU

ACIST MEDICAL SYSTEMS, INC.

Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use

• Primary Device ID: 10841716100755
• NIH Device Record Key: 0a83a139-4e71-49cf-a4c9-92c6584f458a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIST Kodama® Coronary Imaging Catheter
• Version Model Number: 017788
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10841716100755 [Primary]
GS1	20841716101438 [Package]; Package: Shelf box [5 Units]; In Commercial Distribution
GS1	30841716101213 [Package]; Package: Shelf Box [5 Units]; In Commercial Distribution
GS1	30841716101435 [Package]; Contains: 20841716101438; Package: Single Pack [1 Units]; In Commercial Distribution
GS1	30841716102289 [Package]; Package: Shelf Box [5 Units]; In Commercial Distribution

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

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: 2020-03-04
• Device Publish Date: 2016-09-09

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