FDA.reportPublic FDA data

Renasol Acid Concentrate

Primary DI
30677964000677
Brand
Renasol Acid Concentrate
Company
MEDIVATORS INC.
Model
SB-1019
Published
2016-09-20
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
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
K843963000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K843963000DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWDRenal Systems, Inc.1985-01-07FKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30677964000677PackageGS14In Commercial Distribution
00677964000676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3067796400067730677964000677
00677964000676006779640006766779640006760677964000676

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
068199363
Device count
1
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
true
Expiration date on label
false
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
00677964154133Endo Carry-on Procedure Kit401156440115642026-10-28
00677964154140Endo Carry-on Procedure Kit401156540115652026-10-28
00677964154157Endo Carry-on Procedure Kit401156740115672026-10-28
00677964154164Endo Carry-on Procedure Kit401157740115772026-10-28
00677964154171Endo Carry-on Procedure Kit401157840115782026-10-28
00677964154188Endo Carry-on Procedure Kit401169040116902026-10-28
00677964154195Endo Carry-on Procedure Kit401168040116802026-10-28
00677964154201Endo Carry-on Procedure Kit401168240116822026-10-28
00677964154218Endo Carry-on Procedure Kit401168340116832026-10-28
00677964154225Endo Carry-on Procedure Kit401168440116842026-10-28
00677964154232Endo Carry-on Procedure Kit401168540116852026-10-28
00677964154249Endo Carry-on Procedure Kit401168640116862026-10-28
00677964154256Endo Carry-on Procedure Kit401158140115812026-10-28
00677964154263Endo Carry-on Procedure Kit401168140116812026-10-28
00677964154270Endo Carry-on Procedure Kit401169640116962026-10-28
00677964154287Endo Carry-on Procedure Kit401169740116972026-10-28
00677964154294Endo Carry-on Procedure Kit401170240117022026-10-28
00677964154300Endo Carry-on Procedure Kit401170140117012026-10-28
00677964154317Endo Carry-on Procedure Kit401171240117122026-10-28
00677964154324Endo Carry-on Procedure Kit401171340117132026-10-28

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
40677964023987Actril Residual Test StripsMEDIVATORS INC.FKQ2018-07-09
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