FDA.reportPublic FDA data

Perassay 500 Peracetic Acid Test Strips

Primary DI
10677964009119
Brand
Perassay 500 Peracetic Acid Test Strips
Company
MEDIVATORS INC.
Model
78378-000
Catalog number
78378000
Device description
Perassay 500 Peracetic Acid 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
FKQSystem, Dialysate Delivery, Central Multiple Patient
JOJIndicator, physical/chemical sterilization process
LIFDialyzer reprocessing system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKQSystem, Dialysate Delivery, Central Multiple PatientGastroenterology, Urology2
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2
LIFDialyzer Reprocessing SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K830575000
K861730000
K931935000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K830575000RENALIN (TENTATIVERenal Systems, Inc.1983-03-31LIF
K861730000ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, Inc.1987-06-09FKQ
K931935000ENDPOINT 500 PERACETIC ACID TEST INDICATORSMinntech Corp.1994-02-07JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10677964009119PrimaryGS10
00677964009112Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067796400911910677964009119
00677964009112006779640091126779640091120677964009112

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
100
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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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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