FDA.reportPublic FDA data

WELLDOC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30087709573008770957WELLDOC1N2026-01-0110221 Wincopin Cir Ste 150 Columbia MD US 21044

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1244211257202091K230813BlueStar and BlueStar RxNDC2023-07-28
1244211604609804K203434BlueStar RxNDC2021-09-08
1244211857333119K193654BlueStar RxMRZ2020-04-07
1244212071141706K190013WellDoc BlueStarMRZ2019-11-04
1244211881674197K162532WellDoc BlueStar, WellDoc BlueStar RxMRZ2017-01-12
1244211509503009K162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemMRZ2016-11-22
1244211507845526K141273WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTEMRZ2014-07-08
1244211845915020K120314WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMMRZ2012-02-24
1244211042018462K112370WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMMRZ2011-10-14
1244211035827326K100066DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1MRZ2010-07-15
1244211517135307
1244211955016079
1244212045774108

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MRZ82020-04-07
NDC22023-07-28