FDA.reportPublic FDA data

Actril Residual Test Strips

Primary DI
40677964023987
Brand
Actril Residual Test Strips
Company
MEDIVATORS INC.
Model
78258-000
Published
2018-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FKQSystem, Dialysate Delivery, Central Multiple Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKQSystem, Dialysate Delivery, Central Multiple PatientGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K861730000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861730000ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, Inc.1987-06-09FKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30677964008253PackageGS1100In Commercial Distribution
40677964023987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3067796400825330677964008253
4067796402398740677964023987

GMDN Terms#

Term, Definition table
TermDefinition
Peracetic acid device disinfectant/sterilant test stripA sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of peracetic acid in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
068199363
Device count
1
Lot or batch
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
04046963178116Diacap®B.Braun Avitum AGFKQ2022-11-21
04046963178109Diacap®B.Braun Avitum AGFKQ2022-11-21
40677964016729Actril Cold SterilantMEDIVATORS INC.FKQ2020-03-24
40677964016736Actril Cold SterilantMEDIVATORS INC.FKQ2020-03-24
10677964105972Actril Indicator Test StripsMEDIVATORS INC.FKQ2018-12-04
00677964082214Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2018-07-13
10677964008259Actril Residual Test StripsMEDIVATORS INC.FKQ2018-07-09
10677964009119Perassay 500 Peracetic Acid Test StripsMEDIVATORS INC.FKQ2018-07-09
00677964091766Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2018-06-15
30677964091767Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2018-06-15
00677964000249Actril Cold SterilantMEDIVATORS INC.FKQ2018-02-26
00677964000294Actril Cold SterilantMEDIVATORS INC.FKQ2018-02-26
30677964000240Actril Cold SterilantMEDIVATORS INC.FKQ2018-02-26
30677964000295Actril Cold SterilantMEDIVATORS INC.FKQ2018-02-26
00677964044281Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-21
00677964000300Centrisol Bicarbonate Concentrate PowderMEDIVATORS INC.FKQ2016-09-20
00677964000317Centrisol Bicarbonate Concentrate PowderMEDIVATORS INC.FKQ2016-09-20
00677964000324Centrisol Bicarbonate Concentrate PowderMEDIVATORS INC.FKQ2016-09-20
00677964000331Renasol Bicarbonate Concentrate PowderMEDIVATORS INC.FKQ2016-09-20
00677964000348Renasol Bicarbonate Concentrate PowderMEDIVATORS INC.FKQ2016-09-20
00677964000355Renasol Bicarbonate Concentrate PowderMEDIVATORS INC.FKQ2016-09-20
00677964000393Renasol Liquid Bicarbonate ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000409Centrisol Liquid Bicarbonate ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000485Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000492Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000508Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000515Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000522Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000539Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000546Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20