FDA.reportPublic FDA data

Rapicide PA High-Level Disinfectant

Primary DI
00724995245962
Brand
Rapicide PA High-Level Disinfectant
Company
MEDIVATORS INC.
Model
ML020117
Catalog number
ML020117
Device description
Rapicide PA High-Level Disinfectant, Intl Part A, 5 Ltr, and Part B Solutions, 5 Ltr, Assembly
Published
2026-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEBAccessories, cleaning, for endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEBAccessories, Cleaning, For EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082988000MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANTMedivators Reprocessing Systems2009-02-13FEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995245969PackageGS12In Commercial Distribution
20724995245966PackageGS12In Commercial Distribution
50724995245967PackageGS14In Commercial Distribution
00677964063619PreviousGS10
00724995245962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499524596910724995245969
2072499524596620724995245966
5072499524596750724995245967
00677964063619006779640636196779640636190677964063619
00724995245962007249952459627249952459620724995245962

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection agentA non-patient-contact substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses). It may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase), and may be intended to decalcify equipment. The medical device is intended to be exposed to the substance to achieve disinfection through bathing, wiping, and/or in combination with a disinfection device. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
068199363
Device count
1
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
00677964021695CER-1CER-178399-7232016-09-20
00677964033858DSD-201DSD-201 120VDSD20172016-09-20
00677964035647SSD-102SSD-102SSD20072016-09-20
00677964044755Advantage Plus Endoscope Reprocessing System1-2-510.0032016-09-16
00677964046674DSD Edge Endoscope Reprocessing SystemDSD Edge 120VDSD30082016-09-16
00677964052484CER-1 OptimaCER-1 OptimaCER1OPTIMA2016-09-20
00677964052491CER-2 OptimaCER-2 OptimaCER2OPTIMA2016-09-20
00677964095832Advantage Plus Pass-Thru1-2-610.003126100032018-02-06
00677964153877Endo Carry-on Procedure Kit401137340113732026-07-20
00677964153921Endo Carry-on Procedure Kit401139040113902026-07-20
00677964153976Endo Carry-on Procedure Kit401141240114122026-07-20
00677964154089Endo Carry-on Procedure Kit401144940114492026-07-20
00677964154096Endo Carry-on Procedure Kit401146040114602026-07-20
00677964051555Medivators HookupHookup58112CAS2024-04-01
00677964053450Medivators HookupHookup28338CAS2024-04-01
00677964002328Medivators HookupHookup28718CAS2023-04-10
00677964037856Medivators HookupHookup28612CAS2023-04-10
00677964153617Endo Carry-on Procedure Kit401122140112212026-05-26
00677964153624Endo Carry-on Procedure Kit401124240112422026-05-26
00677964153631Endo Carry-on Procedure Kit401123040112302026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10724995245969Rapicide PA High-Level DisinfectantMEDIVATORS INC.FEB2026-03-06
00724995244392NASTERIS CORPORATIONFEB2025-10-21
00724995355470NASTERIS CORPORATIONFEB2025-10-21
00724995355487NASTERIS CORPORATIONFEB2025-10-21
40677964055322Medivators HookupMEDIVATORS INC.FEB2025-06-10
40677964054448Medivators HookupMEDIVATORS INC.FEB2025-04-04
40677964054622Medivators HookupMEDIVATORS INC.FEB2025-04-04
00860010835241System 83 RevolveWassenburg Medical, Inc.FEB2025-02-24
04260306710577SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
04260306710584SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
10705037069316EVOTECH™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FEB2024-06-20
00724995225209NASTERIS CORPORATIONFEB2024-06-03
00724995225216NASTERIS CORPORATIONFEB2024-06-03
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