FDA UDI
In Commercial Distribution
🇺🇸 United States
Vivid
DI: 00195278516343
·
Model: E v203 v204 to v206 UPG
·
GE Vingmed Ultrasound AS
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vivid
- Primary DI
- 00195278516343
- Version / Model
- E v203 v204 to v206 UPG
- Company Name
- GE Vingmed Ultrasound AS
- Labeler DUNS
- 518870571
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-12
- Public Version
- 1
- Public Version Date
- 2022-08-22
- Public Version Status
- New
- Public Device Record Key
- 84e41cbe-0c14-4d84-9db6-38aadbdd347a
Device Description
Vivid E95, E90, E80 v203 v204 to v206 UPG
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 2 |
| OBJ | Catheter, ultrasound, intravascular | Cardiovascular | 870.1200 | 2 |
| IYO | System, imaging, pulsed echo, ultrasonic | Radiology | 892.1560 | 2 |
| IYN | System, imaging, pulsed doppler, ultrasonic | Radiology | 892.1550 | 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 | 00195278516343 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220882 | 000 |