FDA.reportPublic FDA data

PRIMO PASSI

Matched from indexed company URL: Primo Passi LLC

FDA Registration(s)#

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

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
00850000125469Primo Passi - Primo Passi Ear and Forehead Thermometer, Model SK-158 (JPD-FR300). Electrically powered, non-contact infrared thermometer intended for the measurement of human body temperature via the ear canal or forehead. Automatically switches between ear mode and forehead mode based on probe cover position. Features passive infrared receiving technology with advanced infrared temperature sensor. Provides measurement results in approximately 1 second with a single button operation. Includes fever alert function and automatic temperature calibration. Displays temperature in Celsius or Fahrenheit. Forehead mode applicable to all age groups. Ear mode applicable to children older than 3 months, adults, and elderly. Child mode available for users under 12 years of age. Automatic power-off function. Powered by 2 AAA batteries. BPA-free materials. Single-use patient, multiple-use device.888-233-3198sales@primopassi.com
00850065139272Primo Passi - Primo Passi Double Electric Hands-Free Wearable Breast Pump, Model XB-8791. Electrically powered, double-sided wearable breast pump designed to fit inside a bra without external tubing. Intended for use by lactating women for the expression of breast milk. Features 3 operating modes (Stimulation, Expression, and Automatic), 9 adjustable suction levels, and up to 280 mmHg maximum suction pressure. Silent motor operation (less than 45 dB). USB Type-C rechargeable battery. Digital LED display. BPA-free materials. Single-use patient, multiple-use device.888-233-3198sales@primopassi.com

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

GUDID#

Primo Passi - Primo Passi Ear and Forehead Thermometer, Model SK-158 (JPD-FR300). Electrically powered, non-contact infrared thermometer intended for the measurement of human body temperature via the ear canal or forehead. Automatically switches between ear mode and forehead mode based on probe cover position. Features passive infrared receiving technology with advanced infrared temperature sensor. Provides measurement results in approximately 1 second with a single button operation. Includes fever alert function and automatic temperature calibration. Displays temperature in Celsius or Fahrenheit. Forehead mode applicable to all age groups. Ear mode applicable to children older than 3 months, adults, and elderly. Child mode available for users under 12 years of age. Automatic power-off function. Powered by 2 AAA batteries. BPA-free materials. Single-use patient, multiple-use device.

Primo Passi LLC

2026-03-27

Primo Passi - Primo Passi Double Electric Hands-Free Wearable Breast Pump, Model XB-8791. Electrically powered, double-sided wearable breast pump designed to fit inside a bra without external tubing. Intended for use by lactating women for the expression of breast milk. Features 3 operating modes (Stimulation, Expression, and Automatic), 9 adjustable suction levels, and up to 280 mmHg maximum suction pressure. Silent motor operation (less than 45 dB). USB Type-C rechargeable battery. Digital LED display. BPA-free materials. Single-use patient, multiple-use device.

Primo Passi LLC

2026-03-26