FDA.reportPublic FDA data

RenovaRP

Primary DI
00893029002175
Brand
RenovaRP
Company
GI Supply, Inc.
Model
GIS-32
Catalog number
GIS-32
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
2021-07-06
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970187000RUNYON LARGE VOLUME PARACENTESIS KITGi Supply1997-02-14LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10893029002172PackageGS15In Commercial Distribution
00893029002175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089302900217210893029002172
00893029002175008930290021758930290021750893029002175

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
160990313
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00893029002762JADA System10471962026-07-17
00893029002786JADA System5000512026-07-17
00893029002809JADA System5000622026-07-17
00893029002823JADA System5000522026-07-17
00893029002830JADA System8000126/5000612026-07-17
00893029002854JADA System5000632026-07-17
00893029002878JADA System10501372026-07-17
00893029002892JADA System10503452026-07-17
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
00893029002236RenovaRPGIS-31GIS-312021-07-08
00893029002731RenovaRPGIS-35GIS-352023-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160530702HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530719HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530726HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530740HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530771HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530788HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530818HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530825HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530894HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530900HalyardAVID MEDICAL, INC.LRO2026-08-19
10885632530845SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530852SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530869SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530876SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530883SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530913SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
B098AMS197320Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-19
10198956361003CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956510678CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956516915CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956542273CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956549609CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956555303CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10809160530276HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530283HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530306HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530313HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530320HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530344HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530351HalyardAVID MEDICAL, INC.LRO2026-08-18