FDA.reportPublic FDA data

TabloCart™ with Prefiltration Drawer

Primary DI
00850001011297
Brand
TabloCart™ with Prefiltration Drawer
Company
Outset Medical, Inc.
Model
PN-0006988
Device description
Prefiltration Drawer (Packaged), an optional medical device accessory to the Tablo® Hemodialysis System
Published
2024-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
FIPSubsystem, Water Purification
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIPSubsystem, Water PurificationGastroenterology, Urology2
KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232776000Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerOutset Medical, Inc.2024-05-03KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001011297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001011297008500010112978500010112970850001011297

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788744477
Device count
1
Serial number
true
Manufacturing date on label
true

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
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
00860013284107Carbon TankBTI FiltrationFIP2026-10-27
00860013284114Mixed Bed DI tankBTI FiltrationFIP2026-10-27
00860013284121Mixed Bed DI tankBTI FiltrationFIP2026-10-27
00860013284138Mixed Bed DI tankBTI FiltrationFIP2026-10-27
00860013284145Carbon TankBTI FiltrationFIP2026-10-27
00860013284152Carbon TankBTI FiltrationFIP2026-10-27
00860013284169Carbon TankBTI FiltrationFIP2026-10-27
00860013284176Carbon TankBTI FiltrationFIP2026-10-27
07332414202422PRISMAFLEX ST60 SETVantive Health GmbHKDI2026-10-23
07332414202439PRISMAFLEX ST100 SETVantive Health GmbHKDI2026-10-23
07332414202446PRISMAFLEX ST150 SETVantive Health GmbHKDI2026-10-23
07332414124731TherMaxVantive Health GmbHKDI2026-10-21
07332414126018PrismaxVantive Health GmbHKDI2026-10-21
04039361273590multiFluxFresenius Medical Care Holdings, Inc.KDI2026-09-29
04039361273613multiFluxFresenius Medical Care Holdings, Inc.KDI2026-09-29
07332414202309TherMaxVantive Health GmbHKDI2026-07-06
08056992333536HEMOCOR HPH MINI - PEDIATRICMEDICA SPAKDI2026-07-06
07332414200183RevaclearVantive Health GmbHKDI2026-05-29
08056992333543HPH-700 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333550HPH-700TS HEMOCONCENTRATMEDICA SPAKDI2026-04-01
08056992333567HPH-400 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333574HPH-1000 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333581HPH-1400 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333598HPH-400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333604HPH-1000TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333611HPH-1400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333628HPH JUNIORMEDICA SPAKDI2026-04-01
RO0258E-2436RO, 8640GPD, 208V, 4MEMBETTER WATER, LLCFIP2024-11-13
00850001011303TabloCart™ with Prefiltration DrawerOutset Medical, Inc.KDI2024-05-17
00850001011303TabloCart™ with Prefiltration DrawerOutset Medical, Inc.FIP2024-05-17