FDA.reportPublic FDA data

RenovaRP

Primary DI
00893029002236
Brand
RenovaRP
Company
GI Supply, Inc.
Model
GIS-31
Catalog number
GIS-31
Device description
The Laborie RenovaRP® Centesis Kit is intended to be used in conjunction with the RenovaRP Pump, 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 Kit is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis.
Published
2021-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10893029002233PackageGS15In Commercial Distribution
00893029002236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089302900223310893029002233
00893029002236008930290022368930290022360893029002236

GMDN Terms#

Term, Definition table
TermDefinition
Pleurocentesis/paracentesis kitA collection of sterile surgical devices intended for acute (i.e., non-indwelling) therapeutic or diagnostic aspiration of fluids or air from the pleural and/or peritoneal cavities. It includes a dedicated needle, syringe, and appropriate support devices (e.g., dressings, drapes); it does not include a drainage catheter and does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-451-5797info@gi-supply.com

Regulatory Flags#

DUNS number
160990313
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00893029002595MoonPants SMGIS-7-SMGIS-7-SM2021-07-20
00893029002601MoonPants MLGIS-7-MLGIS-7ML2021-07-20
00893029002618MoonPants XLGIS-7-XLGIS-7-XL2021-07-20
00893029002625MoonPants LongGIS-13GIS-132021-07-20
00893029002632SportShorts XSSL-9XSSL-9XS2021-07-20
00893029002649SportShorts SMSL-9SMSL-9SM2021-07-20
00893029002656SportShorts MLSL-9MLSL-9ML2021-07-20
00893029002663SportShorts XLSL-9XLSL-9XL2021-07-20
00893029002243EverLiftGIS-59GIS-592021-02-18
00893029002229EverLiftGIS-55GIS-552021-02-18
00893029002175RenovaRPGIS-32GIS-322021-07-06
00893029002731RenovaRPGIS-35GIS-352023-12-14
00893029002168RenovaRPGIS-30GIS-302022-08-10
00893029002151RenovaRPGIS-29GIS-292021-07-07
00893029002076RenovaRPGIS-27GIS-272016-09-24
10893029002165RenovaRP Tube SetGIS-30GIS-302022-08-10
10893029002592MoonPants SMGIS-7-SMGIS-7-SM2021-07-20
10893029002608MoonPants MLGIS-7-MLGIS-7ML2021-07-20
10893029002615MoonPants XLGIS-7-XLGIS-7-XL2021-07-20
10893029002622MoonPants LongGIS-13GIS-132021-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956074668CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956119260CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956286719CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956386303CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956387959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956420076CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956425996CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956457119CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956459878CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462007CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462151CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956473478CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956475427CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956483675CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956485068CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956490956CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491496CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491533CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491908CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491953CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956492219CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956492615CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956493902CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956494435CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956494558CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956496996CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497375CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497450CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497696CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09