FDA UDI
In Commercial Distribution
🇺🇸 United States
Evolve Breast Pump, PAS
DI: 00865278000486
·
Model: 10-0152
·
HYGEIA II MEDICAL GROUP INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Evolve Breast Pump, PAS
- Primary DI
- 00865278000486
- Version / Model
- 10-0152
- Company Name
- HYGEIA II MEDICAL GROUP INC
- Labeler DUNS
- 033147467
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-05
- Public Version
- 1
- Public Version Date
- 2018-08-06
- Public Version Status
- New
- Public Device Record Key
- ef8ee784-2440-4ae6-a2ae-84c0f92bf786
Device Description
A hospital grade double electric breast pump, powered by AC or battery power, used to extract milk from a mother’s breast. The milk will be collected and used to feed infants. The device permits a user to vary the suction strength, and with the use of accessory parts to collect and funnel the breast milk into storage containers. The device utilizes protective measures to prevent the build-up of excessive negative pressure
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 | 00865278000486 | GS1 |