Outset Medical Inc

FDA Filings

This page includes the latest FDA filings for Outset Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010355846
• FEI Number: 3010355846
• Name: Outset Medical, Inc.
• Owner & Operator: Outset Medical, Inc.
• Contact Address: 3052 Orchard Drive ; San Jose CA 95134 US
• Official Correspondent:
  • Jennifer Mascioli-Tudor
  • 001-669-2318235-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3052 Orchard Drive ; San Jose, CA 95134 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 00850001011358 Outset Medical, Inc.	Tablo(R) Hemodialysis System	2025-09-29
GUDID 00850001011341 Outset Medical, Inc.	Tablo(R) Hemodialysis System	2025-09-29
GUDID 00850001011266 Outset Medical, Inc.	Tablo(R) Hemodialysis System	2025-09-29
GUDID 10850001011218 Outset Medical, Inc.	Tablo(R) Cartridge PN-0004220	2025-05-14
GUDID 00850001011242 Outset Medical, Inc.	Tablo(R) Cartridge PN-0004220	2025-05-14
GUDID 00850001011259 OUTSET MEDICAL, INC.	Tablo(R) Cartridge PN-0004220	2024-05-29
GUDID 00850001011303 OUTSET MEDICAL, INC.	TabloCart™ with Prefiltration Drawer	2024-05-27
GUDID 00850001011297 OUTSET MEDICAL, INC.	TabloCart™ with Prefiltration Drawer	2024-05-27
GUDID 00850001011204 OUTSET MEDICAL, INC.	Tablo(R) Hemodialysis System	2024-05-07
GUDID 00850001011273 OUTSET MEDICAL, INC.	Tablo(R) Cartridge PN-0004220	2024-01-30
PMN K211370 Outset Medical, Inc.	Tablo Hemodialysis System	2022-07-29
PMN K210782 Outset Medical, Inc.	Tablo Cartridge	2021-11-26
GUDID 10850001011164 OUTSET MEDICAL, INC.	Tablo(R) Straws PN-0004467, PN-0005451	2020-08-11
GUDID 10850001011133 OUTSET MEDICAL, INC.	Tablo(R) Straws	2020-08-11
GUDID 00850001011181 OUTSET MEDICAL, INC.	Tablo(R) Disinfectant Straws PN-0004675	2020-08-11
GUDID 00850001011105 OUTSET MEDICAL, INC.	Tablo Hemodialysis Concentrate A-125	2020-08-11
PMN K200741 Outset Medical, Inc.	Tablo Hemodialysis System	2020-03-31
PMN K190793 | KDI Outset Medical, Inc.	Tablo? Straws	2020-01-08
PMN K190793 | KDI Outset Medical, Inc.	Tablo? Script	2020-01-08
PMN K190793 | KDI Outset Medical, Inc.	Tablo? Hemodialysis System	2020-01-08
PMN K190793 | KDI Outset Medical, Inc.	Tablo? Cartridge	2020-01-08
PMN K190793 | FJK Outset Medical, Inc.	Tablo? Straws	2020-01-08
PMN K190793 | FJK Outset Medical, Inc.	Tablo? Script	2020-01-08
PMN K190793 | FJK Outset Medical, Inc.	Tablo? Hemodialysis System	2020-01-08
PMN K190793 | FJK Outset Medical, Inc.	Tablo? Cartridge	2020-01-08
PMN K190793 | FIP Outset Medical, Inc.	Tablo? Straws	2020-01-08
PMN K190793 | FIP Outset Medical, Inc.	Tablo? Script	2020-01-08
PMN K190793 | FIP Outset Medical, Inc.	Tablo? Hemodialysis System	2020-01-08
PMN K190793 | FIP Outset Medical, Inc.	Tablo? Cartridge	2020-01-08
PMN K160881 | KDI Outset Medical, Inc.	Tablo? Straws	2020-01-08
PMN K160881 | KDI Outset Medical, Inc.	Tablo? Script	2020-01-08
PMN K160881 | KDI Outset Medical, Inc.	Tablo? Console	2020-01-08
PMN K160881 | FIP Outset Medical, Inc.	Tablo? Straws	2020-01-08
PMN K160881 | FIP Outset Medical, Inc.	Tablo? Script	2020-01-08
PMN K160881 | FIP Outset Medical, Inc.	Tablo? Console	2020-01-08
PMN K190793 Outset Medical, Inc.	Tablo Hemodialysis System, Tablo Cartridge	2019-12-12
GUDID 10850001011072 OUTSET MEDICAL, INC.	Tablo Cartridge CART-200	2019-06-07
GUDID 00850001011143 OUTSET MEDICAL, INC.	Tablo(R) Cartridge CART-301	2019-06-07
GUDID 00850001011082 OUTSET MEDICAL, INC.	Tablo Needleless Cartridge, B CART-201	2019-06-07
GUDID 00850001011013 OUTSET MEDICAL, INC.	Tablo Cartridge CART-100	2019-06-07
GUDID 00850001011112 OUTSET MEDICAL, INC.	Tablo(R) Hemodialysis System PN-0003000	2019-02-21
GUDID 20850001011024 OUTSET MEDICAL, INC.	Tablo Straws ST-100	2019-02-13
GUDID 10850001011058 OUTSET MEDICAL, INC.	Tablo Hemodialysis Concentrate A-325	2019-02-13
GUDID 10850001011041 OUTSET MEDICAL, INC.	Tablo Hemodialysis Concentrate A-225	2019-02-13
GUDID 00850001011037 OUTSET MEDICAL, INC.	Tablo Hemodialysis Concentrate B-100	2019-02-13
GUDID 00850001011006 OUTSET MEDICAL, INC.	Tablo Hemodialysis Console	2019-02-13
PMN K160881 OUTSET MEDICAL, INC.	Tablo Console	2016-11-15
PMN K140841 | FJK Outset Medical, Inc.	Tablo Cartridge	2014-09-11

Related Finance Registrations

NCAGE Code	5LLN1	OUTSET MEDICAL, INC.!DBA HD+
CAGE Code	5LLN1	OUTSET MEDICAL, INC. HD+
S.A.M. Registration	5LLN1 [788744477]	OUTSET MEDICAL, INC. HD+
SEC	0001484612	Outset Medical, Inc. of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090434767	Laem Chabang,Thailand -> Long Beach, California	MEDICAL SUPPLIES	963 CTN
2020090434767	Laem Chabang,Thailand -> Long Beach, California	MEDICAL SUPPLIES	963 CTN
2020090336926	Laem Chabang,Thailand -> Long Beach, California	MEDICAL SUPPLIES	963 CTN
2020090336926	Laem Chabang,Thailand -> Long Beach, California	MEDICAL SUPPLIES	963 CTN