FDA UDI
In Commercial Distribution
🇺🇸 United States
MISSAA
DI: 06970303251406
·
Model: 918
·
Shantou Huihengqi Electronic Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MISSAA
- Primary DI
- 06970303251406
- Version / Model
- 918
- Company Name
- Shantou Huihengqi Electronic Technology Co., Ltd
- Labeler DUNS
- 542341613
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-19
- Public Version
- 1
- Public Version Date
- 2023-05-29
- Public Version Status
- New
- Public Device Record Key
- 0a8ff39b-034d-44df-aa2b-e7ff1b0bc3a5
Device Description
The Electric Breast Pump are powered breast pumps intended to express and collect milk from a lactating woman’s breast. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The Electric Breast Pump is provided non-sterile and should be cleaned and disinfected according to the instructions for use prior to first use. The user employs buttons on the pump unit to select the pumping mode and vacuum leve
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 | 06970303251406 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211024 | 000 |