ACIST Kodama® Coronary Imaging Catheter

GUDID 10841716100755

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

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

OBJ	Catheter, Ultrasound, Intravascular

Steralize Prior To Use	false
Device Is Sterile	true

10841716100755	Kodama Catheter, p/n 701470-001 Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extensi
10841716103602	Kodama Catheter, Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile