FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925003491
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
190-4
Device description
Tubing With Male Connector For 194 Ellik Evacuator
Published
2016-10-11
Public version status
Update
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
00821925003491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925003491008219250034918219250034910821925003491

GMDN Terms#

Term, Definition table
TermDefinition
Bladder evacuator, reusableA hand-operated device that is attached to a resectoscope and used to suction tissue and body fluids that are released during a transurethral resection (TUR) procedure. It typically consists of a glass or plastic container, a squeeze bulb, tubing and a connector/adaptor for connection to the resectoscope. It is filled with sterile water and vigorously squeezed to force the water through the resectoscope to irrigate and evacuate tissue fragments, blood clots, or calculi from the urinary bladder; these are caught and trapped within the evacuator so as not to be returned to the bladder when the device is squeezed again. Commonly known as an Ellik evacuator. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925014206Gyrus ACMI1404202015-10-24
00821925014213Gyrus ACMI1404212015-10-24
00821925014237Gyrus ACMI1404232015-10-24
00821925014244Gyrus ACMI1404252015-10-24
00821925014251Gyrus ACMI1404262015-10-24
00821925014268Gyrus ACMI1404272015-10-24
00821925014299Gyrus ACMI1404342015-10-24
00821925014558Gyrus ACMI1403402015-10-24
00821925014565Gyrus ACMI1403412015-10-24
00821925014572Gyrus ACMI1404102015-10-24
00821925014589Gyrus ACMI1404112015-10-24
00821925014596Gyrus ACMI1404122015-10-24
00821925014619Gyrus ACMI1404152015-10-24
00821925014626Gyrus ACMI1404162015-10-24
00821925014640Gyrus ACMI1404182015-10-24
00821925014916Gyrus ACMI1403302015-10-24
00821925015210Gyrus ACMI1403312015-10-24
00821925015227Gyrus ACMI1403322015-10-24
00821925015234Gyrus ACMI1403332015-10-24
00821925015241Gyrus ACMI1403342015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973356551721TriousShenzhen Trious Medical Technology Co., LtdKQT2026-06-23
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
00860002476148Intussusception Air Reduction Bulb & Gauge with Plastic CaseGRI 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