FDA UDI
In Commercial Distribution
🇺🇸 United States
EKOS™ +
DI: 00191506015503
·
Model: H74939605135120
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EKOS™ +
- Primary DI
- 00191506015503
- Version / Model
- H74939605135120
- Catalog Number
- H74939605135120
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-20
- Public Version
- 1
- Public Version Date
- 2022-09-28
- Public Version Status
- New
- Public Device Record Key
- 5d99abf0-3672-40fb-86ad-335eacf773f9
Device Description
Endovascular Device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| KRA | Catheter, continuous flush | Cardiovascular | 870.1210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59223 | Ultrasound thrombolysis system catheter, pulmonary | A flexible tube designed for the percutaneous intravascular administration of high-frequency, low-energy ultrasound and drugs [e.g., tissue plasminogen activator (tPA)] for the disruption of clotted blood (i.e., a thrombus or thromboembolus) in the pulmonary arterial system. It typically consists of a side-hole drug infusion catheter with a multi-element ultrasound core wire. The ultrasound is intended to prepare the clot by unwinding the fibrin strands, therefore enabling increased drug permeation through the clot to the vessel wall. It is a component of a system that includes a control unit to deliver the ultrasound. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191506015503 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2.62 | Millimeter | |
| Device Size Text, specify | Treatment Zone Lenght: 12cm | ||
| Length | 135 | Centimeter |