Thorasys Thoracic Medical Systems Inc

FDA Filings

This page includes the latest FDA filings for Thorasys Thoracic Medical Systems 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: 3011331794
• FEI Number: 3011331794
• Name: THORASYS THORACIC MEDICAL SYSTEMS INC.
• Owner & Operator: THORASYS Thoracic Medical Systems inc.
• Contact Address: 6560 Avenue de l'Esplanade suite 103; Montreal CA-QC Quebec H2V4L5 CA
• Official Correspondent:
  • Sebastien Jutras
  • 1-514-3848555-x
• US Agent:
  • David Lennarz
  • Registrar Corp
  • 757 2240177
  • 757 2240179
  • david.lennarz@registrarcorp.com
• Importing Logistics Registration:
  • Importer: Allergic Disease & Asthma Center
  • Address: 1202 E. Butler Rd. ; Greenville, SC 29607 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Allergy & Asthma Associates of Southern California
  • Address: 27800 Medical Center Rd Suite 244 ; Mission Viejo, CA 92691 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Allergy Asthma and Sinus Center
  • Address: 8585 W. Forest Home Avenue Suite 200 ; Greenfield, WI 53228 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Allergy Partners of Chapel Hill
  • Address: 101 Cosgrove Ave., Ste. 110 ; Chapel Hill, NC 27514 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Allergy Partners of Western North Carolina
  • Address: 14 McDowell Street ; Asheville, NC 28801 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Aventiv Research Inc.
  • Address: 7293 Sawmill Rd, Suite 150 ; Dublin, OH 43016 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Brigham and Womens Hospital
  • Address: 75 Francis St., Surgery Building, Suite 155 ; Boston, MA 02115 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Centro De Neumologia Pediatrica
  • Address: 735 Ave. Ponce de Leon Torre Medica Auxilio Mutuo Suite 215 ; San Juan, PR 00917 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Children's Hospital Colorado
  • Address: 13123 E 16th Ave ; Aurora, CO 80045 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Children's Hospital of Orange County
  • Address: 455 South Main St. ; Orange, CA 92868 UNITED STATES
  • Importer Type: END USER
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6560 Avenue de l'Esplanade suite 103; Montreal Quebec, H2V4L5 CA
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07540261021817 Thorasys Thoracic Medical Systems Inc	tf C-100 Kit Vitalograph - Healthcare Edition (28500)	2024-09-30
GUDID 07540261021107 Thorasys Thoracic Medical Systems Inc	tremoflo C-100 Airwave Oscillometry System & Accessories - Ganshorn EU	2024-09-30
GUDID 07540261020698 Thorasys Thoracic Medical Systems Inc	tF Calibrated Reference Load 15cmH2O (2 Years Edition)	2024-09-30
GUDID 07540261017612 Thorasys Thoracic Medical Systems Inc	tf C-100 Kit Vitalograph - Clinical Trial Edition (28300)	2024-09-30
GUDID 07540261020797 Thorasys Thoracic Medical Systems Inc	tremoflo C-100 Kit - Ganshorn SpiroDef Mouthpiece Variant Edition 102079	2024-04-22
GUDID 07540261019234 Thorasys Thoracic Medical Systems Inc	tremoflo C-100 Airwave Oscillometry - Support Arm	2021-11-11
GUDID 07540261010590 Thorasys Thoracic Medical Systems Inc	TremoFlo C-100 Calibrated Reference Load 15 cm H2O.s/L	2021-11-11
GUDID 07540261025853 Thorasys Thoracic Medical Systems Inc	tremoflo C-100 Airwave Oscillometry System & Acces	2018-08-20
GUDID 07540261016400 Thorasys Thoracic Medical Systems Inc	Assembly of tremoflo US software and digital user	2018-07-06
GUDID 07540261015243 Thorasys Thoracic Medical Systems Inc	tremoflo C-100 Airwave Oscillometry System & Acces	2018-07-06
GUDID 07540261014215 Thorasys Thoracic Medical Systems Inc	Clearflo PFT Filter in bag	2018-07-06
GUDID 07540261013454 Thorasys Thoracic Medical Systems Inc	tremoFlo US Software	2018-07-06
GUDID 07540261013362 Thorasys Thoracic Medical Systems Inc	tF C-100 Unit-ClearFlo PFT filter compatible	2018-07-06
GUDID 07540261009860 Thorasys Thoracic Medical Systems Inc	TremoFlo C-100 Calibrated Reference Load 2 cm H2O.	2018-07-06
PMN K170185 | PNV THORASYS THORACIC MEDICAL SYSTEMS INC.	TremoFlo C-100 Airwave Oscillometry System	2017-12-15
PMN K170185 THORASYS Thoracic Medical Systems, Inc.	TremoFlo C-100 Airwave Oscillometry System	2017-09-12

Related Finance Registrations

NCAGE Code	L0L91	THORASYS THORACIC MEDICAL SYSTEMS INC
CAGE Code	L0L91	THORASYS THORACIC MEDICAL SYSTEMS INC
S.A.M. Registration	L0L91 [257777701]	THORASYS THORACIC MEDICAL SYSTEMS INC