Irhythm Technologies Inc

FDA Filings

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

USA

NASDAQ

IRTC

DUNS 861237670

FDA Registration(s)

• Registration Number: 3007208829
• FEI Number: 3007208829
• Name: IRHYTHM TECHNOLOGIES, INC.
• Owner & Operator: iRhythm Technologies, Inc.
• Contact Address: 699 8th St Suite 600; San Francisco CA 94103 US
• Official Correspondent:
  • Rich Laguna
  • x-415-6325700-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 699 8th Street Suite 600; San Francisco, CA 94103 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3008363157
• FEI Number: 3008363157
• Name: iRhythm Technologies, Inc. Orange County
• Owner & Operator: iRhythm Technologies, Inc.
• Contact Address: 699 8th St Suite 600; San Francisco CA 94103 US
• Official Correspondent:
  • Rich Laguna
  • x-415-6325700-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 11085 Knott Ave Ste B ; Cypress, CA 90630 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00850043907046 IRHYTHM TECHNOLOGIES, INC.	Zio ECG Utilization Software (ZEUS) System	2024-08-05
GUDID 00869770000241 IRHYTHM TECHNOLOGIES, INC.	Zio monitor	2022-05-11
PMN K202527 IRhythm Technologies, Inc.	Zio ECG Utilization Software (ZEUS) System	2021-05-21
PMN K202359 IRhythm Technologies, Inc.	Zio Monitor	2021-05-21
GUDID 00869770000234 IRHYTHM TECHNOLOGIES, INC.	ZIO SR Patch	2019-11-08
GUDID 00869770000210 IRHYTHM TECHNOLOGIES, INC.	ZIO AT Patch	2019-11-08
GUDID 00869770000203 IRHYTHM TECHNOLOGIES, INC.	ZIO XT Patch	2019-11-08
PMN K190593 | DQK IRHYTHM TECHNOLOGIES, INC.	Zio ECG Utilization Service (ZEUS) System	2019-09-04
PMN K190593 IRhythm Technologies, Inc.	Zio XT ECG Monitoring System, Zio AT ECG Monitoring System	2019-08-23
PMN K181502 IRhythm Technologies, Inc.	Zio AT ECG Monitoring System, ZEUS System	2018-08-29
PMN K163512 | DXH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Patch	2017-09-01
PMN K163512 | DXH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Gateway	2017-09-01
PMN K163512 | DXH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	ZEUS System	2017-09-01
PMN K163512 | DXH IRHYTHM TECHNOLOGIES, INC.	Zio? AT Patch	2017-09-01
PMN K163512 | DXH IRHYTHM TECHNOLOGIES, INC.	Zio? AT Gateway	2017-09-01
PMN K163512 | DXH IRHYTHM TECHNOLOGIES, INC.	ZEUS System	2017-09-01
PMN K163512 | DSI iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Patch	2017-09-01
PMN K163512 | DSI iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Gateway	2017-09-01
PMN K163512 | DSI iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	ZEUS System	2017-09-01
PMN K163512 | DSI IRHYTHM TECHNOLOGIES, INC.	Zio? AT Patch	2017-09-01
PMN K163512 | DSI IRHYTHM TECHNOLOGIES, INC.	Zio? AT Gateway	2017-09-01
PMN K163512 | DSI IRHYTHM TECHNOLOGIES, INC.	ZEUS System	2017-09-01
PMN K163512 | DSH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Patch	2017-09-01
PMN K163512 | DSH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Gateway	2017-09-01
PMN K163512 | DSH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	ZEUS System	2017-09-01
PMN K163512 | DSH IRHYTHM TECHNOLOGIES, INC.	Zio? AT Patch	2017-09-01
PMN K163512 | DSH IRHYTHM TECHNOLOGIES, INC.	Zio? AT Gateway	2017-09-01
PMN K163512 | DSH IRHYTHM TECHNOLOGIES, INC.	ZEUS System	2017-09-01
PMN K163512 | DQK iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Patch	2017-09-01
PMN K163512 | DQK iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Gateway	2017-09-01
PMN K163512 | DQK iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	ZEUS System	2017-09-01
PMN K163512 | DQK IRHYTHM TECHNOLOGIES, INC.	Zio? AT Patch	2017-09-01
PMN K163512 | DQK IRHYTHM TECHNOLOGIES, INC.	Zio? AT Gateway	2017-09-01
PMN K163512 | DQK IRHYTHM TECHNOLOGIES, INC.	ZEUS System	2017-09-01
LWK iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Razor	2017-09-01
KOY iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Tape Remover Pad	2017-09-01
PMN K163512 IRHYTHM TECHNOLOGIES, INC.	Zio AT ECG Monitoring System	2017-06-02
PMN K143513 IRhythm Technologies, Inc.	ZIO SR ECG Monitoring Service	2015-06-19
PMN K142681 IRhythm Technologies, Inc.	ZEUS (ZIO ECG Utilization Service) System	2014-11-21
PMN K121319 | DSH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? XT Patch	2012-12-26
PMN K121319 | DSH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? XT Patch CE	2012-12-26
PMN K121319 | DSH IRHYTHM TECHNOLOGIES, INC.	Zio? XT Patch	2012-12-26
PMN K121319 | DSH IRHYTHM TECHNOLOGIES, INC.	Zio? XT Patch CE	2012-12-26
PMN K121319 IRHYTHM TECHNOLOGIES, INC.	ZIO PATCH	2012-07-18
PMN K113862 IRHYTHM TECHNOLOGIES, INC.	ZIO PATCH	2012-02-06
PMN K091075 IRHYTHM TECHNOLOGIES, INC.	ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM	2009-07-21
PMN K090363 IRHYTHM TECHNOLOGIES, INC.	ZIO PATCH, MODEL Z100	2009-05-08
PMN K081471 IRHYTHM TECHNOLOGIES, INC.	ECARD AND CCARD	2008-06-24

Related Finance Registrations

NCAGE Code	61MH9	IRHYTHM TECHNOLOGIES, INC.
CAGE Code	61MH9	IRHYTHM TECHNOLOGIES, INC.
S.A.M. Registration	61MH9 [861237670]	IRHYTHM TECHNOLOGIES, INC.
SEC	0001388658	iRhythm Technologies, Inc. of DELAWARE