FDA.reportPublic FDA data

Xen Rinse 5G

Primary DI
05060478112235
Brand
Xen Rinse 5G
Company
QUADRALENE LIMITED
Model
XV1479/19NA
Catalog number
6036002201
Device description
Rinse Additive for use in washer-disinfectors and cart washers. Steam and EtO permeable.
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
FLGCleaner, Ultrasonic, Medical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060478112235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060478112235050604781122355060478112235

GMDN Terms#

Term, Definition table
TermDefinition
Instrument rinsing agentA liquid substance with a neutral or acidic pH intended for the rinsing of medical/surgical instruments (e.g., specula, forceps) after machine cleaning and prior to full sterilization. It is typically a phosphoric acid (H3PO4) in an aqueous solution that neutralizes the alkaline residues from detergents and water (acidic rinse), or lubricants and drying activators (neutral rinse) and may be added, as specified by the manufacturer, to an automated washer. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
218111037
Device count
1
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
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
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
Primary DIBrandCompanyProduct codePublished
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