Cook CollectEVAC

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name: Cook CollectEVAC FDA UDI
Generic Name: Urological irrigation set FDA UDI
Device Name: Cook CollectEVAC FDA UDI
Model / Reference: CCE-10 FDA UDI
Description: Cook CollectEVAC FDA UDI

Identifiers

Catalog Number: G51549 FDA UDI
Primary DI / UDI-DI: 00841436108614 FDA UDI
FDA Product Code: KQT FDA UDI
GMDN Term: Urological irrigation set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4370 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Length — 18.3 Centimeter FDA UDI
Height — 17.8 Centimeter FDA UDI

Category: Urological irrigation set

Cook CollectEVAC by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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AMSure® TUR/Bladder Irrigation Set Y-Type — AMSINO INTERNATIONAL, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Civco Medical Instruments Co., Inc.

Sources (1)

FDA UDI 0db1f474-419f-4c77-828d-b9144480da5f 37 fields · synced Jun 8, 2026