Breas Medical Inc

FDA Filings

This page includes the latest FDA filings for Breas 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	3010817335
FEI Number	3010817335
Name	BREAS MEDICAL, INC.
Owner & Operator	BREAS MEDICAL, INC.
Contact Address	16 Esquire Road N Billerica MA 01862 US
Official Correspondent	Ari Sobel 001-617-2865570-x
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	16 Esquire Road N Billerica, MA 01862 US
Establishment Type	Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00859477004161 BREAS MEDICAL, INC.	HUMAN DESIGN MEDICAL HD60-1017	2019-04-19
GUDID 00859477004123 BREAS MEDICAL, INC.	HUMAN DESIGN MEDICAL HD60-1007	2019-04-19
GUDID 00859477004116 BREAS MEDICAL, INC.	HUMAN DESIGN MEDICAL HD60-7010	2019-04-19
GUDID 00859477004017 BREAS MEDICAL, INC.	HUMAN DESIGN MEDICAL HD60-1005	2019-04-19
GUDID 00859477004000 BREAS MEDICAL, INC.	HUMAN DESIGN MEDICAL HD60-1010	2019-04-19
PMN K140929 \| BZD BREAS MEDICAL, INC.	Z2 CPAP System	2014-12-11
PMN K140929 \| BZD BREAS MEDICAL, INC.	Z2 Auto	2014-12-11
PMN K140929 \| BZD BREAS MEDICAL, INC.	Z1 CPAP System	2014-12-11
PMN K140929 \| BZD BREAS MEDICAL, INC.	Z1 Auto	2014-12-11
PMN K140929 \| BZD BREAS MEDICAL, INC.	Slim Style CPAP Tube and Accessories	2014-12-11
PMN K140929 \| BZD BREAS MEDICAL, INC.	Powershell	2014-12-11
PMN K121374 \| BZD BREAS MEDICAL, INC.	Z1 CPAP unit	2014-04-21
PMN K121374 \| BZD BREAS MEDICAL, INC.	Z1 CPAP Powershell	2014-04-21

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091634439	Shanghai ,China (Mainland) -> Seattle, Washington	TURBO FAN TF037F2000F . .	1 PKG
2020082160208	Yantian,China (Mainland) -> Tacoma, Washington	007987 Z1 UNIT CARTON CN BLACK . .	272 CTN
2020082160225	Yantian,China (Mainland) -> Tacoma, Washington	PLASTIC PARTS .	28 CTN
2020080164064	Yantian,China (Mainland) -> Tacoma, Washington	PLASTIC PARTS .	108 CTN
2020061342609	Shanghai ,China (Mainland) -> Tacoma, Washington	TURBO FAN TF037F2000F . .	2 PKG
2020061020410	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	SMALL Z1 BOX/ BASEBOARD OF UPPER COVER/BASEBO ARD OF BOTTOM COVER	117 PKG
2020060846834	Yantian,China (Mainland) -> Tacoma, Washington	PLASTIC PARTS .	47 CTN
2020060846835	Yantian,China (Mainland) -> Tacoma, Washington	PLASTIC PARTS .	61 CTN