FDA UDI
In Commercial Distribution
🇺🇸 United States
Paradise® Generator
DI: 00810008950128
·
Model: PRDS-USG-2X
·
Recor Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Paradise® Generator
- Primary DI
- 00810008950128
- Version / Model
- PRDS-USG-2X
- Catalog Number
- PRDS-USG-2X
- Company Name
- Recor Medical, Inc.
- Labeler DUNS
- 943549670
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-11
- Public Version
- 1
- Public Version Date
- 2023-12-19
- Public Version Status
- New
- Public Device Record Key
- f2134098-6918-467e-80a5-6b7b1e8867af
Device Description
PRDS-USG-2X Paradise® Generator with Paradise® Remote
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 |
|---|---|---|---|---|
| QYI | Ablation Catheter, Renal Denervation | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65656 | Renal denervation ultrasound system generator | An electrically-powered component of an ultrasound renal denervation system intended to: 1) generate a high frequency electrical current for subsequent conversion to ultrasound energy by a system catheter (not included); and 2) control the flow of cooling solution (e.g., sterile water) intended to prevent arterial wall damage, during renal denervation (RDN). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810008950128 | GS1 |
Customer Contacts
- Phone
- +16505427700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P220023 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 65 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 65 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 85 Percent (%) Relative Humidity