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
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
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841436122061Verza Guidance System653-003653-0032026-07-23
00841436122672Needle Guide667-186667-1862026-07-23
00841436125338Biopsy Bracket667-195667-1952026-07-23
00841436125413Tracking Bracket Starter Kit657-106657-1062026-07-23
00841436125444Cradle657-108657-1082026-07-23
00841436125451Classic Stepper657-109657-1092026-07-23
00841436125819Biopsy Bracket642-522642-5222026-07-23
00841436125833Needle Guide Bracket642-524642-5242026-07-23
00841436125857Needle Guide Bracket642-526642-5262026-07-23
00841436126045Verza Guidance System657-110657-1102026-07-23
00841436126281Biopsy Bracket657-116657-1162026-07-23
00841436126304Biopsy Bracket657-118657-1182026-07-23
00841436126656Multi-Purpose Workstation ™ Stepper610-2561610-25612026-07-23
00841436126663Cradle610-2562610-25622026-07-23
00841436126670Storage System610-2559610-25592026-07-23
00841436126687Storage System610-2560610-25602026-07-23
10841436122662Needle Guide667-188667-188, 667-188-52025-12-31
00841436126311Tracking Bracket Starter Kit657-119657-1192025-12-31
00841436125482Needle Guide11820737118207372026-04-17
00841436108300TEE Kit811-050811-0502017-08-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973356551721TriousShenzhen Trious Medical Technology Co., LtdKQT2026-06-23
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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
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00812261019413Tur Vac ALLWIN MEDICAL DEVICES, INC.KQT2020-09-22
00724995183783BioVacUS EndoscopyKQT2020-04-01
00724995183790BioVacUS EndoscopyKQT2020-04-01
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10724995183780BioVacUS EndoscopyKQT2020-04-01
10724995183797BioVacUS EndoscopyKQT2020-04-01
10724995183803BioVacUS EndoscopyKQT2020-04-01
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00841436104579CollectEVACCIVCO MEDICAL INSTRUMENTS CO., INC.KQT2018-01-03
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