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
00850018480888Primo Passi9229SK-3512026-09-21
00850000125506Primo PassiXB-8732SK-2502026-09-19
00850018480895Primo Passi9229SK-3302026-09-19
00850000125469Primo PassiJPD-FR300SK-1582026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06940657923557WillowGuangdong Horigen Mother & Baby Products Co., Ltd.HGX2026-10-28
08809108020307SpectraUZINMEDICARE CO.,LTDHGX2026-10-28
08809108020338SpectraUZINMEDICARE CO.,LTDHGX2026-10-28
08809108020345SpectraUZINMEDICARE CO.,LTDHGX2026-10-28
06975740364177MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-10-23
16975740363917MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-10-23
06975740363477MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
06975740363484MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
06975740363750MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
06975740363767MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
00850000125506Primo PassiPrimo Passi LLCHGX2026-09-19
09420060218022haakaaTHINK GREEN LIMITEDHGX2026-09-18
09420060218053haakaaTHINK GREEN LIMITEDHGX2026-09-18
04897152760014eufy Wearable Breast PumpAnker Innovations LimitedHGX2026-08-21
07640108055903Breast shell sterile DeTach 12 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055927Breast shell sterile DeTach 13 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055941Breast shell sterile DeTach 14 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055965Breast shell sterile DeTach 15 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055989Breast shell sterile DeTach 16 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108056009Breast shell sterile DeTach 17 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055545Breast shell sterile DeTach 18 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055569Breast shell sterile DeTach 21 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055583Breast shell sterile DeTach 24 mm (2 pcs)Ardo medical AGHGX2026-07-30
06925546002285ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06925546003381ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06925546033821ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06937266900017FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900024FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900031FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900048FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23