ACIST Kodama® Coronary Imaging Catheter

Basic Information

• Brand Name: ACIST Kodama® Coronary Imaging Catheter
• Primary DI: 10841716100755
• Version / Model: 017788
• Company Name: ACIST MEDICAL SYSTEMS, INC.
• Labeler DUNS: 926684994
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 5
• Public Version Date: 2024-02-20
• Public Version Status: Update
• Public Device Record Key: 0a83a139-4e71-49cf-a4c9-92c6584f458a

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44141	Intravascular ultrasound imaging catheter, single-use	A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841716100755	GS1
Package	30841716101213	GS1	Shelf Box	5	Not in Commercial Distribution	2020-07-15
Package	20841716101438	GS1	Shelf box	5	Not in Commercial Distribution	2019-10-02
Package	30841716101435	GS1	Single Pack	1	Not in Commercial Distribution	2019-10-02
Package	30841716102289	GS1	Shelf Box	5	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Frequency: 40/60 Mega HertZ
Device Size Text, specify			Imaging Profile: 3.2 French
Device Size Text, specify			Working Length: 142 Centimeter