FDA.reportPublic FDA data

Primo Passi

Primary DI
00850065139272
Brand
Primo Passi
Company
Primo Passi LLC
Model
XB-8791
Catalog number
SK-376
Device description
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.
Published
2026-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGXPump, Breast, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221598000Wearable breast pumpMayborn (Uk) Limited2022-12-09HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850065139272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850065139272008500651392728500651392720850065139272

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, electricA mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.

Contacts#

Phone, Email table
PhoneEmail
888-233-3198sales@primopassi.com

Regulatory Flags#

DUNS number
080607433
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000125469Primo PassiJPD-FR300SK-1582026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00020451904870Freestyle™ Mini Hands-freeMedela LLCHGX2026-05-01
08809108020017SpectraUZINMEDICARE CO.,LTDHGX2026-04-30
08809108020024SpectraUZINMEDICARE CO.,LTDHGX2026-04-30
19551028430006AmedaTPH TECHNOLOGY MALAYSIA SDN. BHD.HGX2026-03-03
07640108054975Ardo MeliaArdo medical AGHGX2026-02-27
08809108019912SpectraUZINMEDICARE CO.,LTDHGX2026-02-27
16973493597344TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493599430TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493592226MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493592431lansinoh Shenzhen TPH Technology Co., LtdHGX2026-02-25
16973493592530MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493593995MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493594244MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493594374MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493597078MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493597993MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493598235MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493598341MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493599362MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
00020451903873Motion InBra™Medela LLCHGX2026-02-16
00020451903880Motion InBra™Medela LLCHGX2026-02-16
08809108019684SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019691SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019707SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019714SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019769SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019776SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019783SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019790SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019820SpectraUZINMEDICARE CO.,LTDHGX2026-02-03