PRIMO PASSI

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3034993050	3034993050	PRIMO PASSI	1	Y	2026-01-01	7524 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 GUDID	Product	Phone	Email
00850000125469	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.	888-233-3198	sales@primopassi.com
00850000125506	Primo Passi - Primo Passi Portable Dual Charge Electric Breast Pump. Electrically powered, double-sided portable breast pump intended for use by lactating women for the expression of breast milk. Features automatic stimulation and suction modes with adjustable suction levels. Device automatically initiates stimulation mode upon activation, incrementally increasing suction level every 45 seconds until reaching maximum level, then transitions to suction mode. Manual override available. Closed-system design with anti-backflow protection prevents milk contamination. Leak-proof sealing system requires no sealing rings. Innovative joystick controls. Built-in rechargeable lithium battery. Bivolt compatible. LCD display. Includes two baby bottles. BPA-free materials. Single-use patient, multiple-use device.	888-233-3198	sales@primopassi.com
00850018480888	Primo Passi - An electrically powered, handheld, rechargeable massager intended for use on the breast area. The device uses vibration, with an optional heat function, to provide temporary relief of muscle tension, promote relaxation, and temporarily increase local blood circulation. The device body is constructed of soft silicone for ergonomic hand-held use and is intended for personal, non-clinical use.	888-233-3198	sales@primopassi.com
00850018480895	Primo Passi - Primo Passi Baby Electric Nail Filer. Battery-operated grooming device intended for filing the fingernails and toenails of infants and young children. Compact, ergonomic, single-handed design featuring a whisper-quiet motor intended to minimize disturbance during use, including while the child is asleep. Device includes four interchangeable filing head attachments. Ultra Fine, Fine, Medium, and Ultra Gritty to accommodate different nail thicknesses and age ranges. Two-speed operation is selected via a single control button. Filing tip is soft and rounded, designed to reduce the risk of skin contact compared to traditional nail clippers or emery boards. Supplied with a compact storage case. Intended for at-home consumer use by a caregiver. Non-sterile device. Not for prescription use	888-233-3198	sales@primopassi.com
00850065139272	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.	888-233-3198	sales@primopassi.com

primopassi.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
336283	1048017775	K221598	Wearable breast pump	HGX	2022-12-09
336283	1188874237	K202802	TT Electric Breast Pump, TT Double Electric Breast Pump	HGX	2021-08-26
336283	1570008790	K151284	Electric Double Breast Pumps	HGX	2015-12-21
336283	1702282376	K142479	MEGNA BREAST PUMPS	HGX	2015-02-24
336283	1950955973	K131243	NON-CONTACT INFRARED THERMOMETER	FLL	2013-11-12
336283	1047778657
336283	1889468322
336283	2010231098

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
HGX	4	2022-12-09
FLL	1	2013-11-12

GUDID#

Primo Passi - An electrically powered, handheld, rechargeable massager intended for use on the breast area. The device uses vibration, with an optional heat function, to provide temporary relief of muscle tension, promote relaxation, and temporarily increase local blood circulation. The device body is constructed of soft silicone for ergonomic hand-held use and is intended for personal, non-clinical use.
Primo Passi LLC
2026-09-21
Primo Passi - Primo Passi Baby Electric Nail Filer. Battery-operated grooming device intended for filing the fingernails and toenails of infants and young children. Compact, ergonomic, single-handed design featuring a whisper-quiet motor intended to minimize disturbance during use, including while the child is asleep. Device includes four interchangeable filing head attachments. Ultra Fine, Fine, Medium, and Ultra Gritty to accommodate different nail thicknesses and age ranges. Two-speed operation is selected via a single control button. Filing tip is soft and rounded, designed to reduce the risk of skin contact compared to traditional nail clippers or emery boards. Supplied with a compact storage case. Intended for at-home consumer use by a caregiver. Non-sterile device. Not for prescription use
Primo Passi LLC
2026-09-19
Primo Passi - Primo Passi Portable Dual Charge Electric Breast Pump. Electrically powered, double-sided portable breast pump intended for use by lactating women for the expression of breast milk. Features automatic stimulation and suction modes with adjustable suction levels. Device automatically initiates stimulation mode upon activation, incrementally increasing suction level every 45 seconds until reaching maximum level, then transitions to suction mode. Manual override available. Closed-system design with anti-backflow protection prevents milk contamination. Leak-proof sealing system requires no sealing rings. Innovative joystick controls. Built-in rechargeable lithium battery. Bivolt compatible. LCD display. Includes two baby bottles. BPA-free materials. Single-use patient, multiple-use device.
Primo Passi LLC
2026-09-19
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