Home GUDID 00850001011204 Tablo(R) Hemodialysis System
Primary DI 00850001011204
Brand Tablo(R) Hemodialysis System
Company Outset Medical, Inc.
Model PN-0006000
Catalog number PN-0007001
Device description Tablo Console
Published 2020-06-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name FIP Subsystem, Water Purification KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FIP Subsystem, Water Purification Gastroenterology, Urology 2 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850001011204 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850001011204 00850001011204 850001011204 0850001011204
GMDN Terms# Term, Definition table Term Definition Haemodialysis system, institutional/home-use An assembly of mains electricity (AC-powered) devices designed to perform haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. The system typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0 0 Handling Environment Humidity 0 0 Handling Environment Temperature 0 0 Storage Environment Atmospheric Pressure 0 0 Storage Environment Humidity 0 0 Storage Environment Temperature 0 0
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 false Serial number true 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07332414202309 TherMax Vantive Health GmbH KDI 2026-07-06 08056992333536 HEMOCOR HPH MINI - PEDIATRIC MEDICA SPA KDI 2026-07-06 07332414200183 Revaclear Vantive Health GmbH KDI 2026-05-29 08056992333543 HPH-700 HEMOCONCENTRATOR MEDICA SPA KDI 2026-04-01 08056992333550 HPH-700TS HEMOCONCENTRAT MEDICA SPA KDI 2026-04-01 08056992333567 HPH-400 HEMOCONCENTRATOR MEDICA SPA KDI 2026-04-01 08056992333574 HPH-1000 HEMOCONCENTRATOR MEDICA SPA KDI 2026-04-01 08056992333581 HPH-1400 HEMOCONCENTRATOR MEDICA SPA KDI 2026-04-01 08056992333598 HPH-400TS HEMOCONCENTRATOR MEDICA SPA KDI 2026-04-01 08056992333604 HPH-1000TS HEMOCONCENTRATOR MEDICA SPA KDI 2026-04-01 08056992333611 HPH-1400TS HEMOCONCENTRATOR MEDICA SPA KDI 2026-04-01 08056992333628 HPH JUNIOR MEDICA SPA KDI 2026-04-01 00383790012379 Blood pressure cuff for SURDIAL DX Hemodialysis System NIPRO MEDICAL CORPORATION KDI 2025-12-19 00383790012386 Blood pressure cuff for SURDIAL DX Hemodialysis System NIPRO MEDICAL CORPORATION KDI 2025-12-19 00383790012393 Blood pressure cuff for SURDIAL DX Hemodialysis System NIPRO MEDICAL CORPORATION KDI 2025-12-19 00383790012409 Blood pressure cuff for SURDIAL DX Hemodialysis System NIPRO MEDICAL CORPORATION KDI 2025-12-19 00383790012416 Blood pressure cuff hose for SURDIAL DX Hemodialysis System NIPRO MEDICAL CORPORATION KDI 2025-12-19 00383790011914 Nipro Set Blood Tubing Set NIPRO MEDICAL CORPORATION KDI 2025-06-01 RO0258 E-2436RO, 8640GPD, 208V, 4MEM BETTER WATER, LLC FIP 2024-11-13 00850001011303 TabloCart™ with Prefiltration Drawer Outset Medical, Inc. FIP 2024-05-17 00850001011303 TabloCart™ with Prefiltration Drawer Outset Medical, Inc. KDI 2024-05-17 00085412908397 Revaclear Baxter Healthcare SA KDI 2024-04-12 00085412908427 Revaclear Baxter Healthcare SA KDI 2024-04-12 00085412908434 Revaclear Baxter Healthcare SA KDI 2024-04-12 M535NX100010G0 VersiHD with GuideMe software NXSTAGE MEDICAL, INC. KDI 2024-01-25 M535FWS3090 EXPRESS FLUID WARMER DISPOSABLE NXSTAGE MEDICAL, INC. KDI 2023-11-20 08051736007049 CLEARUM HS Mozarc Medical US LLC KDI 2023-08-04 00677964000096 Renaflo II HF 2000 Hemofilter MEDIVATORS INC. FIP 2023-07-18 05060497260153 Bicarbonate Spare Connectors Set QUANTA DIALYSIS TECHNOLOGIES LIMITED KDI 2023-07-13 05060497260160 Quanta Dialysis System QUANTA DIALYSIS TECHNOLOGIES LIMITED KDI 2023-07-03
outsetmedical.com