FDA.reportPublic FDA data

RINSE AID (4 Liter RB38)

Primary DI
00810929011236
Brand
RINSE AID (4 Liter RB38)
Company
Ruhof Corporation
Model
34563-29
Device description
Enzymatic detergents used to clean medical instruments.
Published
2025-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
00810929011236PackageGS14In Commercial Distribution
00810929011229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810929011236008109290112368109290112360810929011236
00810929011229008109290112298109290112290810929011229

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
Handling Environment Temperature40 Degrees Fahrenheit130 Degrees Fahrenheit
Storage Environment Temperature40 Degrees Fahrenheit130 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082779828
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
false
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
00810929045637Liquizime XP (4 Liter RB53)54323-312025-10-17
00810929045644Endozime Premium XP (4 Liter RB53)54324-312025-10-17
00810929045620ENDOZIME BIO-CLEAN NP(4 Liter RB38)34525-292025-09-22
10810929045627ENDOZIME BIO-CLEAN NP(4 Liter RB38)34525-292025-09-22
00810929045613ENDOZIME BIO-CLEAN NP(4 Liter RB38)34525-302025-06-17
00810929010147ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE) 345ESS4F2025-07-11
00810929011410ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE) 345ESS4F2025-07-11
00810929010017ENDOZIME INSTRUSPONGE 1mm (RIGID)345ESS1R2025-07-10
00810929010024ENDOZIME INSTRUSPONGE 1.5mm (RIGID) 345ESS1.5R2025-07-10
00810929010031ENDOZIME INSTRUSPONGE 1.75mm (RIGID) 345ESS2R2025-07-10
00810929010048ENDOZIME INSTRUSPONGE 3mm (RIGID) 345ESS3R2025-07-10
00810929010055ENDOZIME INSTRUSPONGE 5mm (RIGID) 345ESS5R2025-07-10
00810929010062ENDOZIME INSTRUSPONGE 7mm (RIGID) 345ESS7R2025-07-10
00810929010079ENDOZIME INSTRUSPONGE 10mm (RIGID) 345ESS10R2025-07-10
00810929010086ENDOZIME INSTRUSPONGE 12mm (RIGID) 345ESS12R2025-07-10
00810929010093ENDOZIME INSTRUSPONGE 14mm (RIGID) 345ESS14R2025-07-10
00810929010109ENDOZIME INSTRUSPONGE 1mm (FLEXIBLE) 345ESS1F2025-07-10
00810929010123ENDOZIME INSTRUSPONGE 2mm (FLEXIBLE) 345ESS2F2025-07-10
00810929010130ENDOZIME INSTRUSPONGE 3mm (FLEXIBLE) 345ESS3F2025-07-10
00810929010154ENDOZIME INSTRUSPONGE 5mm (FLEXIBLE) 345ESS5F2025-07-10

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
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07340153715929Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
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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