GI SUPPLY

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3014718111	1000121355	GI SUPPLY	1	N	2026-01-01	5069 Ritter Road Suite 104 Mechanicsburg PA US 17055

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00893029002595	MoonPants SM - MoonPants SM single-use non-sterile garment	800-451-5797	info@gi-supply.com
00893029002601	MoonPants ML - MoonPants ML single-use non-sterile garment	800-451-5797	info@gi-supply.com
00893029002618	MoonPants XL - MoonPants XL single-use non-sterile garment	800-451-5797	info@gi-supply.com
00893029002625	MoonPants Long - MoonPants Long single-use non-sterile garment	800-451-5797	info@gi-supply.com
00893029002632	SportShorts XS - SportShorts XS single-use non-sterile garment	800-451-5797	info@gi-supply.com
00893029002649	SportShorts SM - SportShorts SM single-use non-sterile garment	800-451-5797	info@gi-supply.com
00893029002656	SportShorts ML - SportShorts ML single-use non-sterile garment	800-451-5797	info@gi-supply.com
00893029002663	SportShorts XL - SportShorts XL single-use non-sterile garment	800-451-5797	info@gi-supply.com

gi-supply.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
221496	1827166314	K993951	SPOT ENDOSCOPIC MARKER	NBG	2000-02-18
221496	1601635233	K970187	RUNYON LARGE VOLUME PARACENTESIS KIT	LRO	1997-02-14
221496	1402244849	K970186	GI SUPPLY PARACENTESIS PUMP	BTA	1997-02-14
221496	1048615067	K944903	HP-FAST	LYR	1995-04-20
221496	1795451928	K931044	OXY-BLOC	MNK	1993-10-04
221496	1000534364	K253642	Jada System (Jada-2002)	OQY	2026-05-15
221496	1756474822	K221042	Renova RP Centesis Pump	BTA	2023-04-19
221496	1916503010	K212757	Jada System	OQY	2021-09-30
221496	1050112137	K202376	EverLift Submucosal Lifting Agent	PLL	2020-09-30
221496	1277083802	K201199	Jada System	OQY	2020-08-28
221496	1517021231	K191923	EverLift Submucosal Lifting Agent	PLL	2020-06-20
221496	1378658040	K012411	HP-ONE	LYR	2001-09-25
221496	1571667587
221496	1788541120
221496	1788802503
221496	1328810937

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OQY	3	2026-05-15
BTA	2	2023-04-19
PLL	2	2020-09-30
LYR	2	2001-09-25
NBG	1	2000-02-18
LRO	1	1997-02-14
MNK	1	1993-10-04

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#

MoonPants SM - MoonPants SM 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 XL - MoonPants XL 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

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

GI Supply, Inc.

2021-07-20

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

GI Supply, Inc.

2021-07-20

EverLift - Submucosal Lifting Agent - 10mL Single Unit

GI Supply, Inc.

2021-02-18

EverLift - Submucosal Lifting Agent - 5mL 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 - 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 - RenovaRP Fluid Drainage Bag to be used with RenovaRP Centesis Pump - sold in box of 20

GI Supply, Inc.

2021-07-07

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 ML - SportShorts 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

MoonPants ML - MoonPants ML 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 Long - MoonPants Long 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

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

GI Supply, Inc.

2021-07-20

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

GI Supply, Inc.

2021-07-20

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

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

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

Urease - Urease Glycerol Solution

GI Supply, Inc.

2021-07-08

PediaBloc Endoscopy Bite Block - Endoscopy Bite Block

GI Supply, Inc.

2021-07-07

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

Spot Ex CE Endoscopic Tattoo - Spot Ex is indicated for endoscopically tattooing lesions in the GI tract for up to 36 months to facilitate clinical surveillance or surgical localization.

GI Supply, Inc.

2021-07-07

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

PediaBloc Endoscopy Bite Block - Endoscopy Bite Block

GI Supply, Inc.

2021-07-07

Spot Ex CE Endoscopic Tattoo - Spot Ex is indicated for endoscopically tattooing lesions in the GI tract for up to 36 months to facilitate clinical surveillance or surgical localization.

GI Supply, Inc.

2021-07-07

BlueBloc Endoscopy Bite Block - Endoscopy Bite Block

GI Supply, Inc.

2021-07-06

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