FDA.reportPublic FDA data

Tablo Hemodialysis Concentrate

Primary DI
10850001011058
Brand
Tablo Hemodialysis Concentrate
Company
OUTSET MEDICAL, INC.
Model
PN-0000833
Catalog number
A-325
Device description
Liquid acid concentrate, 45X, 3K, 2.5Ca, 1 U.S. gallon
Published
2016-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10850001011058PackageGS14In Commercial Distribution
00850001011051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000101105810850001011058
00850001011051008500010110518500010110510850001011051

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid freezing or storage in excessive heat.
Storage Environment Temperature40 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788744477
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
00850001011303TabloCart™ with Prefiltration DrawerPN-0006813PN-00069882024-05-17
00850001011204Tablo(R) Hemodialysis SystemPN-0006000PN-00070012020-06-17
00850001011273Tablo(R) CartridgePN-0004220PN-00068272024-01-22
00850001011266Tablo(R) Hemodialysis SystemPN-00070002025-09-21
00850001011341Tablo(R) Hemodialysis SystemPN-00070012025-09-21
00850001011358Tablo(R) Hemodialysis SystemPN-00060012025-09-21
00850001011044Tablo Hemodialysis ConcentratePN-0000832A-2252016-01-29
00850001011051Tablo Hemodialysis ConcentratePN-0000833A-3252016-01-29
00850001011075Tablo CartridgePN-0002305CART-2002017-04-11
00850001011136Tablo(R) StrawsPN-00042112020-08-03
00850001011167Tablo(R) StrawsPN-0004378PN-0004467, PN-00054512020-08-03
00850001011174Tablo(R) Disinfectant StrawsPN-0004681PN-00046752020-08-03
00850001011211Tablo(R) CartridgePN-0005643PN-00042202022-04-11
10850001011218Tablo(R) CartridgePN-0005643PN-00042202022-04-11
00850001011242Tablo(R) CartridgePN-0006310PN-00042202022-04-11
00850001011259Tablo(R) CartridgePN-0006887PN-00042202024-05-21
00850001011297TabloCart™ with Prefiltration DrawerPN-00069882024-05-17
00850001011105Tablo Hemodialysis ConcentratePN-0002630A-1252020-08-03
20850001011024Tablo StrawsPN-0000503ST-1002015-11-03
00850001011006Tablo Hemodialysis ConsolePN-00008502015-10-23

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