FDA.reportPublic FDA data

Xen Enzymatic+ 5G

Primary DI
05060478112112
Brand
Xen Enzymatic+ 5G
Company
QUADRALENE LIMITED
Model
XV1755/19NA
Catalog number
6036003001
Device description
A neutral pH, low-foaming, quadruple enzyme detergent for cleaning medical instruments and devices, including flexible endoscopes, using manual methods, ultrasonic, automated washer-disinfectors, including cart washers.
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
05060478112112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060478112112050604781121125060478112112

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10724995218864PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
50724995218848PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
50724995218855PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
00724995231057ProlysticaSTERIS CORPORATIONFLG2026-01-14
00724995231064ProlysticaSTERIS CORPORATIONFLG2026-01-14
00724995231071ProlysticaSTERIS CORPORATIONFLG2026-01-14
10705037018062ENZOL™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018130CIDEZYME™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018154CIDEZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018161CIDEZYME™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
00724995229559PRE-KLENZSTERIS CORPORATIONFLG2025-12-16
D661UC300230CE1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
D661UC50DB230CE1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
D661UC50DB230UK1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
H816GEL121Spec Clean Pre Treatment GelMicroCare, LLCFLG2025-10-23
H816OP1281OptizymeMicroCare, LLCFLG2025-10-23
H816EZ128Spec Clean Single Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816EZTAB641Spec Clean Enzymatic TabletsMicroCare, LLCFLG2025-10-22
H816PCNF128Spec Clean Instrument Detergent AlkalineMicroCare, LLCFLG2025-10-22
H816PLC128Spec Clean Concentrated Instrument LubricantMicroCare, LLCFLG2025-10-22
H816PLR32Spec Clean Instrument LubricantMicroCare, LLCFLG2025-10-22
H816PREZ128Spec Clean Dual Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZ275Spec Clean Dual Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZAW050Spec Clean Quad Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZAW128Spec Clean Quad Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZF128Spec Clean Pre Treatment Foam SprayMicroCare, LLCFLG2025-10-22
H816PREZF240Spec Clean Pre Treatment Foam SprayMicroCare, LLCFLG2025-10-22
H816PRR050Spec Clean Rinse AgentMicroCare, LLCFLG2025-10-22
H816PRR128Spec Clean Rinse AgentMicroCare, LLCFLG2025-10-22
H816PVAC128Spec Clean Evacuation System CleanerMicroCare, LLCFLG2025-10-22