FDA.reportPublic FDA data

Xen QuadX 2x5L

Primary DI
05060478112457
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

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

Regulatory Flags#

DUNS number
218111037
Device count
2
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05060478112341Xen Neutral 5LXV1826/5NA60360032012025-07-25

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Primary DI, Brand, Company table
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