FDA.reportPublic FDA data

Renalin Residual Test Strips

Primary DI
00677964007972
Brand
Renalin Residual Test Strips
Company
MEDIVATORS INC.
Model
78198-000
Catalog number
78198000
Device description
Renalin Residual Test Strips
Published
2018-07-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LIFDialyzer Reprocessing System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIFDialyzer Reprocessing SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K830575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K830575000RENALIN (TENTATIVERenal Systems, Inc.1983-03-31LIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30677964007973PackageGS1100In Commercial Distribution
00677964007972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3067796400797330677964007973
00677964007972006779640079726779640079720677964007972

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)444-4729custserv@MEDIVATORS.com

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
00677964153617Endo Carry-on Procedure Kit401122140112212026-05-26
00677964153624Endo Carry-on Procedure Kit401124240112422026-05-26
00677964153631Endo Carry-on Procedure Kit401123040112302026-05-26
00677964153648Endo Carry-on Procedure Kit401124340112432026-05-26
00677964153655Endo Carry-on Procedure Kit401124440112442026-05-26
00677964153662Endo Carry-on Procedure Kit401124540112452026-05-26
00677964153679Endo Carry-on Procedure Kit401121440112142026-05-26
00677964153686Endo Carry-on Procedure Kit401123640112362026-05-26
00677964153693Endo Carry-on Procedure Kit401123740112372026-05-26
00677964153709Endo Carry-on Procedure Kit401123840112382026-05-26
00677964153716Endo Carry-on Procedure Kit401125040112502026-05-26
00677964153723Endo Carry-on Procedure Kit401125240112522026-05-26
00677964153730Endo Carry-on Procedure Kit401123940112392026-05-26
00677964153747Endo Carry-on Procedure Kit401125140112512026-05-26
00677964153754Endo Carry-on Procedure Kit401125340112532026-05-26
00677964153761Endo Carry-on Procedure Kit401125440112542026-05-26
00677964153778Endo Carry-on Procedure Kit401136040113602026-05-26
00677964153785Endo Carry-on Procedure Kit401136140113612026-05-26
00677964057281Endo Carry-On Procedure Kit1008491008492018-06-22
00677964153488Endo Carry-on Procedure Kit401119340111932026-04-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10677964007979Renalin Residual Test StripsMEDIVATORS INC.LIF2018-07-09
10677964009119Perassay 500 Peracetic Acid Test StripsMEDIVATORS INC.LIF2018-07-09
00898021000235PeraSidualAngelini Pharma Inc.LIF2017-05-23
00898021000242PeraChekAngelini Pharma Inc.LIF2017-05-23
00382830034456NATUS NEUROLOGY NATUS NEUROLOGY INCORPORATEDLIF2017-03-17
00858293006120Micro-XREPROCESSING PRODUCTS CORPORATIONLIF2017-03-07
00851575007044SteriChek® Peroxide Reagent StripsHACH COMPANYLIF2016-09-23
00851575007075SteriChek® Residual Peroxide Reagent StripsHACH COMPANYLIF2016-09-23
00851575007150SteriChek® Peracetic Acid Reagent StripsHACH COMPANYLIF2016-09-23
M17451051Serim® GUARDIAN™ Residual Peroxide Test Strips SERIM RESEARCH CORPORATIONLIF2016-09-08
M17451052Serim® GUARDIAN™ Residual Peroxide Test Strips SERIM RESEARCH CORPORATIONLIF2016-09-08
M17451121Serim® GUARDIAN™ Residual Formaldehyde Test Strips SERIM RESEARCH CORPORATIONLIF2016-09-08
00898021000037Maky 21.1Angelini Pharma Inc.LIF2016-08-29