FDA UDI
In Commercial Distribution
🇺🇸 United States
momcozy
DI: 06975740360438
·
Model: M5-Grey-D
·
Shenzhen Lutejiacheng Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- momcozy
- Primary DI
- 06975740360438
- Version / Model
- M5-Grey-D
- Company Name
- Shenzhen Lutejiacheng Technology Co., Ltd.
- Labeler DUNS
- 411899033
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2023-01-01
- Public Version
- 4
- Public Version Date
- 2023-04-14
- Public Version Status
- Update
- Public Device Record Key
- 4362e688-bd61-428f-9652-739dd3b7aae6
- Distribution End Date
- 2026-01-01
Device Description
The Wearable Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 06975740369097 | GS1 | carton | 12 | Not in Commercial Distribution | 2023-01-01 |
| Primary | 06975740360438 | GS1 | ||||
| Unit of Use | 06975740360445 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223693 | 000 |