FDA UDI
In Commercial Distribution
🇺🇸 United States
SLT IVUS P1 Display Unit
DI: 00850045446031
·
Model: DU0001
·
Provisio Medical, Inc.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SLT IVUS P1 Display Unit
- Primary DI
- 00850045446031
- Version / Model
- DU0001
- Catalog Number
- DU0001
- Company Name
- Provisio Medical, Inc.
- Labeler DUNS
- 015877254
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-24
- Public Version
- 1
- Public Version Date
- 2024-06-03
- Public Version Status
- New
- Public Device Record Key
- 6763dc11-33ce-476c-b6ee-3de1992f40d8
Device Description
See LBL-0998, SLT IVUS P1 System Manual
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | 870.1200 | 2 |
| DQY | Catheter, Percutaneous | Cardiovascular | 870.1250 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40763 | Cardiovascular ultrasound imaging system | An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850045446031 | GS1 |
Customer Contacts
- Phone
- 858-524-3901
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233948 | 000 |