FDA.reportPublic FDA data

RenovaRP Kit No Catheter

Primary DI
10893029002233
Brand
RenovaRP Kit No Catheter
Company
GI Supply, Inc.
Model
GIS-31
Catalog number
GIS-31
Device description
The GI Supply RenovaRP Paracentesis Kit is intended to be used in conjunction with the GI Supply RenovaRP Paracentesis Pump and GI Supply RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity. The GI Supply RenovaRP Paracentesis Kit is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis.
Published
2021-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
160990313
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00893029002175RenovaRPGIS-32GIS-322021-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528365HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528372HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528389HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528419HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528433HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528440HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528457HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528488HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528495HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528501HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528518HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528525HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528532HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528549HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528556HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528570HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528594HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528617HalyardAVID MEDICAL, INC.LRO2026-08-03
10885632528620SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-03
B098AMS16817B0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS17579A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS178930Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS178970Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS191170Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
10809160528341HALYARDAVID MEDICAL, INC.LRO2026-08-01
10198956352315CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956364998CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956395503CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956453180CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956485358CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31