FDA UDI
In Commercial Distribution
🇺🇸 United States
Control 10T Mechanical Thrombectomy Filter
DI: B090ASP10390
·
Model: ASP-1039
·
ZIEN MEDICAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Control 10T Mechanical Thrombectomy Filter
- Primary DI
- B090ASP10390
- Version / Model
- ASP-1039
- Catalog Number
- ASP-1039
- Company Name
- ZIEN MEDICAL TECHNOLOGIES, INC.
- Labeler DUNS
- 017535668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-28
- Public Version
- 1
- Public Version Date
- 2023-04-05
- Public Version Status
- New
- Public Device Record Key
- 6ed1cb3f-b6eb-4f3c-b456-c82ee44dee47
Device Description
The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy Filter is a “tool,” not a “treatment.”
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
- Yes
- 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 |
|---|---|---|---|---|
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65026 | Thrombectomy tubing set, non-electronic | A collection of noninvasive tubing and associated non-powered components (typically connectors, clamps and spikes) designed to conduct fluids from a container (e.g., bag) to a thrombectomy catheter (not included) to assist with the intravascular disruption and removal of clotted blood (i.e., a thrombus or thromboembolus); it does not include invasive devices. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B090ASP10391 | HIBCC | Shelf Carton | 5 | In Commercial Distribution | |
| Primary | B090ASP10390 | HIBCC | ||||
| Package | B090ASP10392 | HIBCC | Shipper | 2 | In Commercial Distribution |