FDA UDI
In Commercial Distribution
🇺🇸 United States
Reprocessed Visions PV.035 Digital IVUS Catheter
DI: 00860036000531
·
Model: VEN-PV-035
·
Vein360 LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reprocessed Visions PV.035 Digital IVUS Catheter
- Primary DI
- 00860036000531
- Version / Model
- VEN-PV-035
- Catalog Number
- VEN-PV-035
- Company Name
- Vein360 LLC
- Labeler DUNS
- 080926907
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-29
- Public Version
- 1
- Public Version Date
- 2023-09-06
- Public Version Status
- New
- Public Device Record Key
- 3e475995-36ae-49a0-a341-c628c74e4a48
Device Description
Reprocessed Visions PV.035 Digital IVUS Catheter
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
- Yes
- 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 |
|---|---|---|---|---|
| OWQ | Reprocessed Intravascular Ultrasound Catheter | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64174 | Intravascular ultrasound imaging catheter, reprocessed | 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 a single or an array of transducer element(s). This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860036000531 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230584 | 000 |