FDA.reportPublic FDA data

RenovaRP

Primary DI
00893029002076
Brand
RenovaRP
Company
GI Supply, Inc.
Model
GIS-27
Catalog number
GIS-27
Device description
The GI Supply Paracentesis Pump is intended as a suction pump to remove ascitic fluid from the abdominal cavity in conjunction with the GI Supply Paracentesis Kit.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTAPump, Portable, Aspiration (Manual Or Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970186000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970186000GI SUPPLY PARACENTESIS PUMPGi Supply1997-02-14BTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00893029002076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00893029002076008930290020768930290020760893029002076

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration system pumpA mains electricity (AC-powered) device used to generate positive and/or negative pressures as part of an irrigation/aspiration system used during a general surgical procedure to intermittently or continuously irrigate and/or aspirate body cavities and wounds. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
160990313
Device count
1
Serial number
true
Manufacturing date on label
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
00893029002236RenovaRPGIS-31GIS-312021-07-08
00893029002175RenovaRPGIS-32GIS-322021-07-06
00893029002731RenovaRPGIS-35GIS-352023-12-14
00893029002168RenovaRPGIS-30GIS-302022-08-10
00893029002151RenovaRPGIS-29GIS-292021-07-07
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
00860014862731HEYVALUEOak Tech LLCBTA2026-03-27
00860014862748GROWNSYOak Tech LLCBTA2026-03-27
10845854041413APEXConmed CorporationBTA2026-03-23
10845854080153CONMEDConmed CorporationBTA2026-03-23
00810149098246R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-02-12
00810149098222R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-01-20
00860014862700GROWNSYOak Tech LLCBTA2026-01-10
00860014862717GROWNSYOak Tech LLCBTA2026-01-10
00860014862724GROWNSYOak Tech LLCBTA2026-01-10
06973222511606Electric Nasal AspiratorShenzhen Desida Technology Co., Ltd.BTA2025-12-31
00810149098178R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-10-27
00860014577550HEYVALUEOak Tech LLCBTA2025-10-13
00860014577567HEYVALUEOak Tech LLCBTA2025-10-13
00860014577574HEYVALUEOak Tech LLCBTA2025-10-13
00860014577581HEYVALUEOak Tech LLCBTA2025-10-13
00860014577505GROWNSYOak Tech LLCBTA2025-08-26
00860014577512GROWNSYOak Tech LLCBTA2025-08-26
00860014577529GROWNSYOak Tech LLCBTA2025-08-26
06953775661706BBLOVEAlicn Medical Shenzhen, Inc.BTA2025-08-04
07640108052506Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit FussschalterArdo medical AGBTA2025-07-16
07640108053374Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115VArdo medical AGBTA2025-07-16
07640108055293Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115VArdo medical AGBTA2025-07-16
00810149097997R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-23
00810149097973R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
00810149097980R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
06975740361558MomcozyShenzhen Root Innovation Technology Co., Ltd.BTA2025-05-20
06978331170218BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170232BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170249BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170256BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31