FDA UDI
In Commercial Distribution
🇺🇸 United States
Paradise® Catheter
DI: 00810008950043
·
Model: PRDS-068-02
·
Recor Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Paradise® Catheter
- Primary DI
- 00810008950043
- Version / Model
- PRDS-068-02
- Catalog Number
- PRDS-068-02
- 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
- 920913bf-e5d8-4369-b76e-7d365106eb2d
Device Description
PRDS-068-02 Paradise® Catheter 8mm
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
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| QYI | Ablation Catheter, Renal Denervation | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65657 | Renal denervation ultrasound system catheter | An electrically-powered, steerable, thin, flexible tube intended to be introduced percutaneously into the renal artery to emit ultrasound energy, with simultaneous arterial wall cooling to prevent arterial wall damage, for renal denervation (RDN). It includes a distal ultrasound transducer and balloon for the circulation of cooling fluids. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810008950043 | GS1 |
Customer Contacts
- Phone
- +16505427700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P220023 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Balloon Diameter | 8 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -18 – 55 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity