FDA UDI
In Commercial Distribution
🇺🇸 United States
Primo Passi
DI: 00850065139272
·
Model: XB-8791
·
Primo Passi LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Primo Passi
- Primary DI
- 00850065139272
- Version / Model
- XB-8791
- Catalog Number
- SK-376
- Company Name
- Primo Passi LLC
- Labeler DUNS
- 080607433
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-26
- Public Version
- 1
- Public Version Date
- 2026-04-03
- Public Version Status
- New
- Public Device Record Key
- 0178f17d-ce11-4aa2-9eb1-2b085fe2ae42
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HGX | Pump, Breast, Powered | Obstetrics/Gynecology | 884.5160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38478 | Breast pump, electric | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850065139272 | GS1 |
Customer Contacts
- Phone
- 888-233-3198
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221598 | 000 |