GI SUPPLY

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• Renova RP Centesis Pump

  2023-04-19

  Gi Supply, Inc.

• EverLift Submucosal Lifting Agent

  2020-09-30

  Gi Supply, Inc.

• EverLift Submucosal Lifting Agent

  2020-06-20

  GI Supply

• GI SUPPLY BILIARY STENT

  2003-09-24

  GI SUPPLY

• HP-ONE

  2001-09-25

  GI SUPPLY

• GI SUPPLY PARACENTESIS PUMP

  1997-02-14

  GI SUPPLY

• RUNYON LARGE VOLUME PARACENTESIS KIT

  1997-02-14

  GI SUPPLY

• HP-FAST

  1995-04-20

  GI SUPPLY

• OXY-BLOC

  1993-10-04

  GI SUPPLY

• BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY

  1992-03-27

  GI SUPPLY

GUDID#

• JADA System - Vacuum-induced Hemorrhage Control System

  GI Supply, Inc.

  2026-07-17

• JADA System - Vacuum-induced Hemorrhage Control System

  GI Supply, Inc.

  2026-07-17

• JADA System - Vacuum-induced Hemorrhage Control System

  GI Supply, Inc.

  2026-07-17

• JADA System - Vacuum-induced Hemorrhage Control System

  GI Supply, Inc.

  2026-07-17

• JADA System - Vacuum-induced Hemorrhage Control System

  GI Supply, Inc.

  2026-07-17

• JADA System - Vacuum-induced Hemorrhage Control System

  GI Supply, Inc.

  2026-07-17

• JADA System - Vacuum-induced Hemorrhage Control System

  GI Supply, Inc.

  2026-07-17

• JADA System - Vacuum-induced Hemorrhage Control System

  GI Supply, Inc.

  2026-07-17

• SportShorts XL - SportShorts XL single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• SportShorts ML - SportShorts ML single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• SportShorts SM - SportShorts SM single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• SportShorts XS - SportShorts XS single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• MoonPants Long - MoonPants Long single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• MoonPants XL - MoonPants XL single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• MoonPants ML - MoonPants ML single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• MoonPants SM - MoonPants SM single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• EverLift - Submucosal Lifting Agent - 5mL Single Unit

  GI Supply, Inc.

  2021-02-18

• EverLift - Submucosal Lifting Agent - 10mL Single Unit

  GI Supply, Inc.

  2021-02-18

• RenovaRP - 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.

  GI Supply, Inc.

  2021-07-06

• RenovaRP - 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.

  GI Supply, Inc.

  2021-07-08

• RenovaRP - 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.

  GI Supply, Inc.

  2023-12-14

• RenovaRP - RenovaRP Fluid Drainage Bag to be used with RenovaRP Centesis Pump - sold in box of 20

  GI Supply, Inc.

  2021-07-07

• RenovaRP - The RenovaRP® Tube Set is intended for use in conjunction with the RenovaRP Centesis Pump 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 Tube Set is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis.

  GI Supply, Inc.

  2022-08-10

• RenovaRP - 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.

  GI Supply, Inc.

  2016-09-24

• RenovaRP Tube Set - RenovaRP Tube Set from GI Supply is intended to be used in conjunction with the RenovaRP Paracentesis Management System to remove ascitic fluid from the abdominal cavity

  GI Supply, Inc.

  2022-08-10

• SportShorts XL - SportShorts XL single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• SportShorts ML - SportShorts ML single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• SportShorts SM - SportShorts SM single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• SportShorts XS - SportShorts XS single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• MoonPants Long - MoonPants Long single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• MoonPants XL - MoonPants XL single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• MoonPants ML - MoonPants ML single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• MoonPants SM - MoonPants SM single-use non-sterile garment

  GI Supply, Inc.

  2021-07-20

• Urease - Urease Glycerol Solution

  GI Supply, Inc.

  2021-07-08

• HpFast - HpFast detects the urease enzyme for the presumptive identification of Helicobacter pylori gastric mucosal biopsies. It is intended for in-vitro diagnostic use only.

  GI Supply, Inc.

  2021-07-08

• HpOne - HpOne detects the urease enzyme for the presumptive identification of Helicobacter pylori in gastric mucosal biopsies. It is intended for in-vitro diagnostic use only.

  GI Supply, Inc.

  2021-07-08

• RenovaRP Kit No Catheter - 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.

  GI Supply, Inc.

  2021-07-08

• OmniBloc Endoscopy Bite Block - Endoscopy Bite Block

  GI Supply, Inc.

  2021-07-07

• UltimaBloc Endoscopy Bite Block - Endoscopy Bite Block

  GI Supply, Inc.

  2021-07-07

• GeneraBloc Endoscopy Bite Block - Endoscopy Bite Block

  GI Supply, Inc.

  2021-07-07

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