FDA UDI
In Commercial Distribution
🇺🇸 United States
RenovaRP
DI: 00893029002731
·
Model: GIS-35
·
GI Supply, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RenovaRP
- Primary DI
- 00893029002731
- Version / Model
- GIS-35
- Catalog Number
- GIS-35
- Company Name
- GI Supply, Inc.
- Labeler DUNS
- 160990313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-14
- Public Version
- 1
- Public Version Date
- 2023-12-22
- Public Version Status
- New
- Public Device Record Key
- 6e18933d-a535-419d-8ce8-a94f0c75de8b
Device Description
The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis. The RenovaRP Centesis Pump is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis.
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 |
|---|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63642 | Surgical suction pump | An electrically-powered device, which may include noninvasive accessories, intended to generate negative pressure for aspiration of body cavities/wounds during a variety of surgical procedures (e.g., general surgery, liposuction, and laparoscopy), typically to facilitate observation; it may also be intended for airway/oral cavity clearance. It is not intended for vascular/thrombectomy use and is not dedicated to thoracic drainage or dental applications; it is not designed for surgical irrigation. The device may incorporate a pressure gauge/controls, and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00893029002731 | GS1 |
Customer Contacts
- Phone
- 800-451-5797
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221042 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal