FDA.reportPublic FDA data

BREAS MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30108173353010817335BREAS MEDICAL, INC.1Y2026-01-0116 Esquire Road N Billerica MA US 01862

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 GUDIDProductPhoneEmail
00859477004000HUMAN DESIGN MEDICAL - Ventilator, Non Continuous Respirator with Battery Source855-436-8729hdmsupport@hdmusa.com
00859477004017HUMAN DESIGN MEDICAL - Ventilator, Non Continuous Respirator855-436-8729hdmsupport@hdmusa.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1703461557536980K242485EveryWareMOD2025-05-20
1703461180652677K242438ClearoNHJ2025-05-16
1703461418399134K240779Vivo 3MNT2024-12-13
1703461410769155K240778Vivo 1, Vivo 2MNS2024-12-13
1703461996832572K233452Vivo 45 LSNOU2025-01-13
1703461387711715K232365Vivo 45 LSCBK2025-12-19
1703461704236416K193586Vivo 45 LSNOU2021-01-27
1703461070452625K160481Vivo 60NOU2016-11-09
1703461995229619K140929Z1 CPAP SYSTEMBZD2014-10-17
1703461164200320K123144VIVO 50NOU2013-06-18
1703461511258666K121374ZI BLOWERBZD2013-02-22
1703461448678254
1703461701022905
1703461911671742

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NOU42025-01-13
BZD42014-10-17
CBK12025-12-19
MOD12025-05-20
NHJ12025-05-16
MNS12024-12-13
MNT12024-12-13

GUDID#