FDA.report

Sanizyme

Primary DI
00848956021287
Brand
Sanizyme
Company
HEALTHMARK INDUSTRIES CO., INC.
Model
6003000835
Device description
Sanizyme 5 Gal
Published
2026-05-22
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

Related Records

Product Codes

CodeName
FLGCleaner, Ultrasonic, Medical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848956021287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848956021287008489560212878489560212870848956021287

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags

DUNS number
057680480
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 DIBrandModelCatalogPublished
00848956021263Sanizyme60030008332026-05-22
00848956021294Sanizyme60030008362026-05-22
00848956021317Sanizyme60030008342026-05-22
10848956020355N/ASGDH24SGDH242025-06-18
10848956020362N/ASGDH36SGDH362025-06-18
10848956020379N/ASGDH40SGDH402025-06-18
10848956020386N/ASGDH45SGDH452025-06-18
00848956020396N/ASGDH48SGDH482025-06-18
00848956020402N/ASGDH54SGDH542025-06-18
10848956007325Decontam Exam GlovesTDG-1-50TDG-1-502024-12-31
10848956007332Decontam Exam GlovesTDG-2-50TDG-2-502024-12-31
10848956007349Decontam Exam GlovesTDG-3-50TDG-3-502024-12-31
10848956007356Decontam Exam GlovesTDG-4-50TDG-4-502024-12-31
10848956007363Ultra Long Decontam Exam GlovesULDG-1-50ULDG-1-502024-12-31
10848956007370Ultra Long Decontam Exam GlovesULDG-2-50ULDG-2-502024-12-31
10848956007387Ultra Long Decontam Exam GlovesULDG-3-50ULDG-3-502024-12-31
10848956007394Ultra Long Decontam Exam GlovesULDG-4-50ULDG-4-502024-12-31
20848956007322Decontam Exam GlovesTDG-1-500TDG-1-5002024-12-31
20848956007339Decontam Exam GlovesTDG-2-500TDG-2-5002024-12-31
20848956007346Decontam Exam GlovesTDG-3-500TDG-3-5002024-12-31

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00848956021263SanizymeHEALTHMARK 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
50724995231052ProlysticaSTERIS CORPORATIONFLG2026-01-14