DEVICE: momcozy (06975740360193)
Device Identifier (DI) Information
momcozy
S9 Pro-grey-D
In Commercial Distribution
Shenzhen Lutejiacheng Technology Co., Ltd.
S9 Pro-grey-D
In Commercial Distribution
Shenzhen Lutejiacheng Technology Co., Ltd.
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
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HGX | Pump, Breast, Powered |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K230776 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
abe87b48-e889-4c13-a1f4-fe3be8ce78a2
July 11, 2023
4
January 01, 2023
July 11, 2023
4
January 01, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 06975740369035 | 16 | 06975740360193 | 2026-01-01 | In Commercial Distribution | carton |
| 06975740369042 | 12 | 06975740360193 | 2026-01-01 | In Commercial Distribution | carton |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
06975740360407
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined