FDA.reportPublic FDA data

Xen Universal+ 15G

Primary DI
05060478112181
Brand
Xen Universal+ 15G
Company
QUADRALENE LIMITED
Model
XV1825/57NA
Catalog number
6036004101
Device description
A concentrated mild alkaline, low-foaming, detergent for cleaning medical instruments and devices using automated washer-disinfectors and cart washers. Compatible with aluminum.
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
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
05060478112181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060478112181050604781121815060478112181

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
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
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
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
05060478112358Xen Neutral+ 5LXV1827/5NA60360033012025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848956021263SanizymeHEALTHMARK INDUSTRIES CO., INC.FLG2026-05-22
00848956021287SanizymeHEALTHMARK INDUSTRIES CO., INC.FLG2026-05-22
00848956021294SanizymeHEALTHMARK INDUSTRIES CO., INC.FLG2026-05-22
00848956021317SanizymeHEALTHMARK INDUSTRIES CO., INC.FLG2026-05-22
00889813067970Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFLG2026-03-22
00889813067987Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFLG2026-03-22
07640397422042StatClean Ultrasonic CleanerDent4You AGFLG2026-03-11
07340153711815Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153711822Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153711839Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153711846Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715837Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715844Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715851Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715882Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715899Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715905Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715912Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715929Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715943Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715974Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716001Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716018Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716025Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716032Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716049Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716056Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716063Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716070Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716087Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25