PRIMO PASSI

FDA Device Registration & Listing · Orlando, FL, US · Registration 3034993050

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3034993050
FEI Number
3034993050
Entity Name
PRIMO PASSI
City/State/Country
Orlando, FL, US
Establishment Address
7524 Currency Dr., Orlando, FL 32809, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Primo Passi (Owner Number: 10092542)
Owner / Operator Contact Address
2637 E. Atlantic Blvd, Pompano Beach, FL 33062, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K202802
PMA Number
N/A

All Registered Proprietary Names

Primo Passi Ear and Forehead Thermomter Primo Passi Wearable Breast Pump Primo Passi Electric Nail Filer Primo Passi Lactation Massager Primo Passi Wearable Breast Pump

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-03-14
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2026-03-10
ILW Adaptor, Grooming Physical Medicine Class 1 890.5050 2026-03-26
BXB Exerciser, Powered Physical Medicine Class 1 890.5380 2025-07-15
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2025-07-15

Official Correspondent

Yaluan Giurizatto

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Primo Passi
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034993050. Last updated year: 2026. Please use registration number 3034993050 when referencing this establishment in official correspondence.
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