FDA.reportPublic FDA data

Renalin Residual Test Strips

Primary DI
10677964007979
Brand
Renalin Residual Test Strips
Company
MEDIVATORS INC.
Model
78198-000
Published
2018-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10677964007979PrimaryGS10
00677964007972Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067796400797910677964007979
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

Regulatory Flags#

DUNS number
068199363
Device count
100
DM exempt
false
Premarket exempt
false
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G212GT23101GlutarTest 1Ibt Scientific LLCLIF2022-01-06
00851575007389Stericide Peroxide Reagent StripsHACH COMPANYLIF2020-04-14
00677964007972Renalin 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