FDA.reportPublic FDA data

Cook CollectEVAC

Primary DI
00827002515499
Brand
Cook CollectEVAC
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
CCE-10
Catalog number
G51549
Device description
Cook CollectEVAC
Published
2018-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
00827002515499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002515499008270025154998270025154990827002515499

GMDN Terms#

Term, Definition table
TermDefinition
Urological irrigation kitA collection of sterile items for the infusion of fluids used to flush out the urethra and bladder. It typically includes tubing, connectors, a syringe, a roller clamp and other items used to flush the bladder. It is typically used in procedures such as a cystoscopy or a transurethral resection (TUR) as a means of continuous irrigation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height17.8Centimeter
Length18.3Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature52 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(319)248-6502james.leong@civco.com

Regulatory Flags#

DUNS number
134614411
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20841436122881Verza Guidance System639-064639-0642025-12-31
20841436125356Verza Guidance System667-196667-1962025-12-31
20841436125516Verza Guidance SystemH48062APH48062AP2025-12-31
20841436125523Needle Guidance SystemH48062ARH48062AR2025-12-31
20841436125530Needle Guidance SystemH48062ASH48062AS2025-12-31
20841436126261Verza Guidance System657-115657-1152025-12-31
20841436126339Verza Guidance System657-117657-1172025-12-31
20841436126346Tracking Bracket Starter Kit657-119657-1192025-12-31
20841436124274Verza Guidance SystemH48062AVH48062AV2025-12-31
00841436122658Needle Guide667-187667-1872025-12-31
00841436122665Needle Guide667-188667-1882025-12-31
00841436126243Needle Guide610-1557610-15572025-12-31
00841436126250Needle Guide610-1558610-15582025-12-31
20841436113087GUS610-2159610-21592024-09-09
20841436122980Biopsy Bracket644-105644-1052024-09-09
20841436125066Biopsy Bracket639-072639-0722024-09-09
20841436122140Biopsy Bracket653-006653-0062024-06-20
20841436123284Needle Guide Bracket676-243676-2432024-06-20
00841436122214Needle Guide842-001842-001, 842-001-52024-06-20
00841436123051Needle Guide842-002842-002, 842-002-52024-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973356557907PUSENShenzhen Trious Medical Technology Co., Ltd.KQT2025-12-08
04055207011911NARichard Wolf GmbHKQT2024-08-19
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
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
00848657013307AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQT2017-11-28
00848657016889AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQT2017-11-28
00821925001053Toomey™ Evacuator 30 cc With AdapterGyrus Acmi, Inc.KQT2016-10-11
00821925001077Toomey™ Evacuator 50 cc With AdapterGyrus Acmi, Inc.KQT2016-10-11
00821925002593Bulb For Ellik Evacuator LatexGyrus Acmi, Inc.KQT2016-10-11
00821925003491Tubing With Male Connector For 194 Ellik EvacuatorGyrus Acmi, Inc.KQT2016-10-11
00821925003538Glass Body For 194 Ellik EvacuatorGyrus Acmi, Inc.KQT2016-10-11
00821925003545USA Elite System™ and USA Series™ Ellik Evacuator Adapter, Non-LockinGyrus Acmi, Inc.KQT2016-10-11
00814334021156NARichard Wolf GmbHKQT2016-09-30
08714729045069NABOSTON SCIENTIFIC CORPORATIONKQT2016-09-24
08714729045076NABOSTON SCIENTIFIC CORPORATIONKQT2016-09-24
08714729033769Urovac Bladder EvacuatorBOSTON SCIENTIFIC CORPORATIONKQT2016-09-24