Outset Medical, Inc.

Matched from indexed company URL: Outset Medical

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3010355846	3010355846	Outset Medical, Inc.	1	N	2026-01-01	3052 Orchard Drive San Jose CA US 95134

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00850001011013	Tablo Cartridge - DWG-3008	844.698.2256	TechnicalService@outsetmedical.com
00850001011037	Tablo Hemodialysis Concentrate - Liquid bicarbonate concentrate, 45X, 1 U.S. gallon	844.698.2256	TechnicalService@outsetmedical.com
00850001011082	Tablo Needleless Cartridge, B - Tablo Cartridge with Needleless Infusion Ports Type B	844.698.2256	TechnicalService@outsetmedical.com

outsetmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
174477	1919025444	K253412	Tablo Hemodialysis System (PN-0008000, PN-0006000U)	KDI	2026-01-26
174477	1115839561	K233335	Tablo® Hemodialysis System	KDI	2023-12-05
174477	1202292973	K232776	Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer	KDI	2024-05-03
174477	1619670028	K223248	Tablo® Hemodialysis System	KDI	2023-06-21
174477	1314545143	K211370	Tablo Hemodialysis System	KDI	2022-07-29
174477	1293092549	K210782	Tablo Cartridge	FJK	2021-11-26
174477	1414581063	K200741	Tablo Hemodialysis System	KDI	2020-03-31
174477	1637956625	K190793	Tablo Hemodialysis System, Tablo Cartridge	KDI	2019-12-12
174477	1776920715	K160881	Tablo Console	KDI	2016-11-15
174477	1965043967	K140841	TABLO CARTRIDGE	FJK	2014-09-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KDI	8	2026-01-26
FJK	2	2021-11-26

PMN#

Tablo® Hemodialysis System; TabloCart? with Prefiltration Drawer
2024-05-03
Outset Medical, Inc.
Tablo® Hemodialysis System
2023-12-05
Outset Medical, Inc.
Tablo® Hemodialysis System
2023-06-21
Outset Medical, Inc.
Tablo Hemodialysis System
2022-07-29
Outset Medical, Inc.
Tablo Cartridge
2021-11-26
Outset Medical, Inc.
Tablo Hemodialysis System
2020-03-31
Outset Medical, Inc.
Tablo Hemodialysis System, Tablo Cartridge
2019-12-12
Outset Medical, Inc.
Tablo Console
2016-11-15
OUTSET MEDICAL, INC.
Tablo Console With Wireless Capability
2015-05-01
Outset Medical

GUDID#

Tablo(R) Hemodialysis System - Tablo Console
Outset Medical, Inc.
2025-09-21
Tablo(R) Hemodialysis System - Tablo Console
Outset Medical, Inc.
2025-09-21
Tablo(R) Hemodialysis System - Tablo Console
Outset Medical, Inc.
2025-09-21
Tablo(R) Cartridge - The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis.
Outset Medical, Inc.
2019-01-11
Tablo(R) Hemodialysis System - The Tablo System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute orchronic care facility.
Outset Medical, Inc.
2019-01-11
Tablo Needleless Cartridge, B - Tablo Cartridge with Needleless Infusion Ports Type B
Outset Medical, Inc.
2017-06-05
Tablo Hemodialysis Concentrate - Liquid bicarbonate concentrate, 45X, 1 U.S. gallon
Outset Medical, Inc.
2016-01-29
Tablo Cartridge - DWG-3008
Outset Medical, Inc.
2015-10-23
Tablo Hemodialysis Console - PN-0000850
Outset Medical, Inc.
2015-10-23
Tablo Straws - PN-0000503
Outset Medical, Inc.
2015-11-03
Tablo Hemodialysis Concentrate - Liquid acid concentrate, 45X, 1K, 2.5Ca, 1 U.S. gallon
Outset Medical, Inc.
2020-08-03
Tablo(R) Cartridge - Tablo Cartridge, Needleless, X, with Formula Organizer
Outset Medical, Inc.
2024-01-22
Tablo(R) Hemodialysis System - Tablo Console
Outset Medical, Inc.
2020-06-17
TabloCart™ with Prefiltration Drawer - Prefiltration Drawer, an optional medical device accessory to the Tablo® Hemodialysis System
Outset Medical, Inc.
2024-05-17
TabloCart™ with Prefiltration Drawer - Prefiltration Drawer (Packaged), an optional medical device accessory to the Tablo® Hemodialysis System
Outset Medical, Inc.
2024-05-17
Tablo(R) Cartridge - Tablo X Cartridge, OMM
Outset Medical, Inc.
2024-05-21
Tablo(R) Cartridge - Tablo X Cartridge with Needleless Infusion Ports
Outset Medical, Inc.
2022-04-11
Tablo(R) Cartridge - Tablo X Cartridge with Needleless Infusion Ports
Outset Medical, Inc.
2022-04-11
Tablo(R) Cartridge - Tablo X Cartridge with Needleless Infusion Ports
Outset Medical, Inc.
2022-04-11
Tablo(R) Disinfectant Straws - Straws for disinfectant bottle
Outset Medical, Inc.
2020-08-03
Tablo(R) Straws - Straws, for concentrate bottles
Outset Medical, Inc.
2020-08-03
Tablo(R) Straws - Straws, for concentrate bottles
Outset Medical, Inc.
2020-08-03
Tablo Cartridge - Tablo Cartridge with Needleless Infusion Ports
Outset Medical, Inc.
2017-04-11
Tablo Hemodialysis Concentrate - Liquid acid concentrate, 45X, 3K, 2.5Ca, 1 U.S. gallon
Outset Medical, Inc.
2016-01-29
Tablo Hemodialysis Concentrate - Liquid acid concentrate, 45X, 2K, 2.5Ca, 1 U.S. gallon
Outset Medical, Inc.
2016-01-29
Tablo(R) Disinfectant Straws - Straws for disinfectant bottle
OUTSET MEDICAL, INC.
2020-08-03
Tablo(R) Straws - Straws, for concentrate bottles
OUTSET MEDICAL, INC.
2020-08-03
Tablo(R) Straws - Straws, for concentrate bottles
OUTSET MEDICAL, INC.
2020-08-03
Tablo Cartridge - Tablo Cartridge with Needleless Infusion Ports
OUTSET MEDICAL, INC.
2017-04-11
Tablo Hemodialysis Concentrate - Liquid acid concentrate, 45X, 3K, 2.5Ca, 1 U.S. gallon
OUTSET MEDICAL, INC.
2016-01-29
Tablo Hemodialysis Concentrate - Liquid acid concentrate, 45X, 2K, 2.5Ca, 1 U.S. gallon
OUTSET MEDICAL, INC.
2016-01-29