FDA.reportPublic FDA data

Tablo Hemodialysis Concentrate

Primary DI
00850001011044
Brand
Tablo Hemodialysis Concentrate
Company
Outset Medical, Inc.
Model
PN-0000832
Catalog number
A-225
Device description
Liquid acid concentrate, 45X, 2K, 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

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850001011041PackageGS14In Commercial Distribution
00850001011044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000101104110850001011041
00850001011044008500010110448500010110440850001011044

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis concentrateA product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.

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

Contacts#

Phone, Email table
PhoneEmail
844.698.2256TechnicalService@outsetmedical.com

Regulatory Flags#

DUNS number
788744477
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001011266Tablo(R) Hemodialysis SystemPN-00070002025-09-21
00850001011341Tablo(R) Hemodialysis SystemPN-00070012025-09-21
00850001011358Tablo(R) Hemodialysis SystemPN-00060012025-09-21
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
00850001011303TabloCart™ with Prefiltration DrawerPN-00068132024-05-17
00850001011204Tablo(R) Hemodialysis SystemPN-00060002020-06-17
00850001011273Tablo(R) CartridgePN-0008544PN-00042202024-01-22
00850001011105Tablo Hemodialysis ConcentratePN-0002630A-1252020-08-03
20850001011024Tablo StrawsPN-0000503ST-1002015-11-03
00850001011006Tablo Hemodialysis ConsolePN-00008502015-10-23
00850001011013Tablo CartridgeDWG-3008CART-1002015-10-23

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
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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