FDA.reportPublic FDA data

PRIMO PASSI

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30349930503034993050PRIMO PASSI1Y2026-01-017524 Currency Dr. Orlando FL US 32809

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3362831048017775K221598Wearable breast pumpHGX2022-12-09
3362831188874237K202802TT Electric Breast Pump, TT Double Electric Breast PumpHGX2021-08-26
3362831570008790K151284Electric Double Breast PumpsHGX2015-12-21
3362831702282376K142479MEGNA BREAST PUMPSHGX2015-02-24
3362831950955973K131243NON-CONTACT INFRARED THERMOMETERFLL2013-11-12
3362831047778657
3362832010231098

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HGX42022-12-09
FLL12013-11-12