FDA UDI
In Commercial Distribution
🇺🇸 United States
Versana
DI: 00840682180535
·
Model: Premier R2 VS
·
GE Medical Systems (China) Co.,Ltd.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Versana
- Primary DI
- 00840682180535
- Version / Model
- Premier R2 VS
- Company Name
- GE Medical Systems (China) Co.,Ltd.
- Labeler DUNS
- 654658731
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-28
- Public Version
- 2
- Public Version Date
- 2021-11-05
- Public Version Status
- Update
- Public Device Record Key
- eae5719d-16d4-4991-9741-7d693eddc088
Device Description
Magna R2 VS Basic console
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
- 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
- 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 |
|---|---|---|---|---|
| IYO | System, imaging, pulsed echo, ultrasonic | Radiology | 892.1560 | 2 |
| IYN | System, imaging, pulsed doppler, ultrasonic | Radiology | 892.1550 | 2 |
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40761 | General-purpose ultrasound imaging system | A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840682180535 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210438 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Handing environment temperature from 3 degree C to 40 degree C without battery.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Handing environment temperature from 10 degree C to 30 degree C with battery
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 50 Degrees Celsius