FDA.reportPublic FDA data

Toomey

Primary DI
00821925001077
Brand
Toomey
Company
Gyrus ACMI, LLC
Model
188A
Device description
Toomey Evacuator 50 cc With Adapter
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
00821925001077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925001077008219250010778219250010770821925001077

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
Ethylene Oxide
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
00821925019157VOCOM1430002015-10-24
00821925019164GYRUS ACMI, INC1430012015-10-24
00821925019171GYRUS ACMI, INC1430022015-10-24
00821925019225GYRUS ACMI, INC1430062015-10-24
00821925019232GYRUS ACMI, INC1430072015-10-24
00821925019249GYRUS ACMI, INC1430082015-10-24
00821925019300GYRUS ACMI, INC1430032015-10-24
00821925019317GYRUS ACMI, INC1430042015-10-24
00821925019324GYRUS ACMI, INC1430052015-10-24
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973356551455ProxivaShenzhen Trious Medical Technology Co., LtdKQT2026-08-18
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