Xen QuadX 2x5L

Primary DI
05060478112068
Brand
Xen QuadX 2x5L
Company
QUADRALENE LIMITED
Model
XV1QDX/2X5NA
Catalog number
6036002501
Device description
A neutral pH, low-foaming, quadruple enzyme detergent for cleaning medical instruments and devices. For use in sinks and ultrasonic cleaners.
Published
2025-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060478112457PrimaryGS10
05060478112068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060478112457050604781124575060478112457
05060478112068050604781120685060478112068

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning agentA substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
218111037
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060478112457Xen QuadX 2x5LXV1QDX/2X5NA60360025012025-07-25
05060478112051Xen XcelerateXV1509/TNA60360024012025-07-25
05060478112075Xen Enzymatic 5LXV1807/5NA60360026012025-07-25
05060478112082Xen Enzymatic 5GXV1807/19NA60360027012025-07-25
05060478112099Xen Enzymatic 15GXV1807/57NA60360028012025-07-25
05060478112105Xen Enzymatic+ 5LXV1755/5NA60360029012025-07-25
05060478112112Xen Enzymatic+ 5GXV1755/19NA60360030012025-07-25
05060478112129Xen Enzymatic+ 15GXV1755/57NA60360031012025-07-25
05060478112136Xen Universal 5LXV1610/5NA60360036012025-07-25
05060478112143Xen Universal 5GXV1610/19NA60360037012025-07-25
05060478112150Xen Universal 15GXV1610/57NA60360038012025-07-25
05060478112167Xen Universal+ 5LXV1825/5NA60360039012025-07-25
05060478112174Xen Universal+ 5GXV1825/19NA60360040012025-07-25
05060478112181Xen Universal+ 15GXV1825/57NA60360041012025-07-25
05060478112228Xen Rinse 5LXV1479/5NA60360021012025-07-25
05060478112235Xen Rinse 5GXV1479/19NA60360022012025-07-25
05060478112242Xen Rinse 15GXV1479/57NA60360023012025-07-25
05060478112310Xen Xcelerate+XV1830/500NA60360051012025-07-25
05060478112327Xen Sanizyme+ 5LXV1SZM/5NA60360052012025-07-25
05060478112334Xen Sanizyme+ 5GXV1SZM/19NA60360053012025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10620974004216Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004223Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004230Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004247Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004254Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004261Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
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