FDA UDI
In Commercial Distribution
🇺🇸 United States
ACIST Kodama® Coronary Imaging Catheter
DI: 10841716103602
·
Model: 017788
·
ACIST MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ACIST Kodama® Coronary Imaging Catheter
- Primary DI
- 10841716103602
- 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
- 2025-08-14
- Public Version
- 1
- Public Version Date
- 2025-08-22
- Public Version Status
- New
- Public Device Record Key
- f8db9845-3864-44c4-bf3e-4c84125ca616
Device Description
Kodama Catheter, Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag
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
- Yes
- 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 | 10841716103602 | GS1 | ||||
| Package | 30841716103606 | GS1 | 5 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193183 | 000 |