FDA.reportPublic FDA data

Intussusception Air Reduction Bulb & Gauge with Plastic Case

Primary DI
00860002476148
Brand
Intussusception Air Reduction Bulb & Gauge with Plastic Case
Company
GRI MEDICAL PRODUCTS INC
Model
IARB-KIT
Catalog number
IARB-KIT
Device description
Intussusception Air Reduction Bulb & Gauge with Plastic Case
Published
2019-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KQTEvacuator, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQTEvacuator, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002476148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002476148008600024761488600024761480860002476148

GMDN Terms#

Term, Definition table
TermDefinition
Gravity enema setA collection of devices intended to be used to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine. It includes a fluid reservoir (e.g., enema bag) which acts as a gravity-flow chamber, and typically includes enema tube(s) and enema tip; it may be prefilled with a non-medicated enema solution and may be available preassembled. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005875146
Device count
1
Premarket exempt
true
Combination product
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860002476100Intussusception Air Reduction Kit with Blue tipIARK-3IARK-32019-12-18
00860002476117Intussusception Air Reduction Kit with Pink TipIARK-2IARK-22019-12-18
00860002476124Intussusception Air Reduction kit, no tipIARK-1IARK-12019-12-18
00860002476131Intussusception Air Reduction Bulb & GaugeIARBIARB2019-12-18
00860002476155Occlusion DiscOD-1OD-12019-12-18
00860002476162Intussusception Pressure Relief ValveIRK-PRV2IARK-PRV22019-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207054390NARichard Wolf GmbHKQT2026-05-19
06973356557754TriousShenzhen Trious Medical Technology Co., Ltd.KQT2026-03-25
06973356557907PUSENShenzhen Trious Medical Technology Co., Ltd.KQT2025-12-08
04055207011911NARichard Wolf GmbHKQT2024-08-19
00724995203306BioVacUS EndoscopyKQT2020-11-23
10724995203303BioVacUS EndoscopyKQT2020-11-23
00801741049057Ellik Bladder EvacuatorC. R. Bard, Inc.KQT2020-09-22
00801741080647Bladder EvacuatorC. R. Bard, Inc.KQT2020-09-22
00812261019413Tur Vac ALLWIN MEDICAL DEVICES, INC.KQT2020-09-22
00724995183783BioVacUS EndoscopyKQT2020-04-01
00724995183790BioVacUS EndoscopyKQT2020-04-01
00724995183806BioVacUS EndoscopyKQT2020-04-01
10724995183780BioVacUS EndoscopyKQT2020-04-01
10724995183797BioVacUS EndoscopyKQT2020-04-01
10724995183803BioVacUS EndoscopyKQT2020-04-01
00860002476100Intussusception Air Reduction Kit with Blue tipGRI MEDICAL PRODUCTS INCKQT2019-12-18
00860002476117Intussusception Air Reduction Kit with Pink TipGRI MEDICAL PRODUCTS INCKQT2019-12-18
00860002476124Intussusception Air Reduction kit, no tipGRI MEDICAL PRODUCTS INCKQT2019-12-18
00860002476131Intussusception Air Reduction Bulb & GaugeGRI MEDICAL PRODUCTS INCKQT2019-12-18
00860002476155Occlusion DiscGRI MEDICAL PRODUCTS INCKQT2019-12-18
00860002476162Intussusception Pressure Relief ValveGRI MEDICAL PRODUCTS INCKQT2019-12-18
00841436104579CollectEVACCIVCO MEDICAL INSTRUMENTS CO., INC.KQT2018-01-03
00841436108614Cook CollectEVACCIVCO MEDICAL INSTRUMENTS CO., INC.KQT2018-01-03
00827002515499Cook CollectEVACCIVCO MEDICAL INSTRUMENTS CO., INC.KQT2018-01-03
00848657013307AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQT2017-11-28
00848657016889AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQT2017-11-28
00821925001053ToomeyGyrus ACMI, LLCKQT2016-10-11
00821925001077ToomeyGyrus ACMI, LLCKQT2016-10-11
00821925002593Gyrus ACMIGyrus ACMI, LLCKQT2016-10-11
00821925003491Gyrus ACMIGyrus ACMI, LLCKQT2016-10-11