Device
Electric Breast Pump
Manufacturer
Fimilla (Shanghai) maternity & baby Articles Co., Ltd
Fimilla (Shanghai) maternity & baby Articles Co., Ltd
Model: HL-3058 II Pro
DI: 06974306710038
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-19
Current Version: 2026-05-27
Description
Electric Breast Pump
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
184cbbb2-780b-42db-8010-3477849ac6bd
Distribution Status:
In Commercial Distribution
DUNS Number:
554458169
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06974306710038
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38478
Name: Breast pump, electric
Definition:
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.
FDA Product Codes
HGX
Pump, Breast, Powered
Premarket Submissions
Submission Number:
K254125
Supplement Number:
000