FDA.reportPublic FDA data

Denise M Oppermann

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30028456513002845651Denise M Oppermann1N2026-01-01920 Winter Street Waltham MA US 02451
30121724163012172416Denise M Oppermann1N2026-01-01920 Winter Street Waltham MA US 02451
30076990733007699073Denise M Oppermann1N2020-04-25920 Winter Street Waltham MA US 02451
30108504713010850471Denise M Oppermann1N2020-04-25920 Winter Street Waltham MA US 02451

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1669271959574465K232926Novalung ultimate kit (US)QJZ2024-04-15
2395501959574465K232926Novalung ultimate kit (US)QJZ2024-04-15
1669271794668762K191407Novalung SystemQJZ2020-02-21
2395501794668762K191407Novalung SystemQJZ2020-02-21
1721851409291591K143617AquaC UNO HFIP2015-10-19
1669271156391924K140181MEDOS HILITE INFANT OXYGENATORDTZ2014-02-19
2031581156391924K140181MEDOS HILITE INFANT OXYGENATORDTZ2014-02-19
1669271898194636K140177MEDOS HILITE OXYGENATORDTZ2014-02-18
2031581898194636K140177MEDOS HILITE OXYGENATORDTZ2014-02-18
1721851103440790K133829AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HFFIP2014-04-22
1669271512970212K133261MEDOS HILITE 7000 & 7000 LT OXYGENATORDTZ2014-01-09
2031581512970212K133261MEDOS HILITE 7000 & 7000 LT OXYGENATORDTZ2014-01-09
1669271849088920

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DTZ62014-02-19
QJZ42024-04-15
FIP22015-10-19