FDA UDI
In Commercial Distribution
🇺🇸 United States
OptEase Vena Cava Filter
DI: 20705032072875
·
Model: 466F230BJ
·
CORDIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OptEase Vena Cava Filter
- Primary DI
- 20705032072875
- Version / Model
- 466F230BJ
- Catalog Number
- 466F230BJ
- Company Name
- CORDIS CORPORATION
- Labeler DUNS
- 806136177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-28
- Public Version
- 5
- Public Version Date
- 2022-08-01
- Public Version Status
- Update
- Public Device Record Key
- 88688b06-3d72-451a-953e-1f0fd64a5c5a
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| DTK | FILTER, INTRAVASCULAR, CARDIOVASCULAR | Cardiovascular | 870.3375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44864 | Vena cava filter, temporary/permanent | A vascular device intended to be percutaneously implanted in the inferior vena cava (IVC) to prevent pulmonary embolism (PE); it can be retrieved before a threshold period or remain as a permanent implant after the period. It achieves its unconstrained diameter upon deployment in the IVC and imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. It is designed for blood clot capture while maintaining caval patency. It is made of metal alloys [e.g., stainless steel, titanium (Ti), nickel-titanium alloy (Nitinol)] and is available in various self-expanding designs (e.g., conical, basket). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20705032072875 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dark, dry place.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use open or damaged packages