Device
101048395
Manufacturer
Medela LLC
Model: 101048395 DI: 00020451904870 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: Yes
First Published: 2026-05-01 Current Version: 2026-05-11
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: da45d5e3-3384-475c-a6e5-647bbca4e832
Distribution Status: In Commercial Distribution
DUNS Number: 052002029
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
Item #1 - Device ID: 00020451904887
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 1
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00020451904870
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00020451904870
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Device ID: 00020451904580
Item #3 - Device ID Type: Direct Marking
Item #3 - Device ID 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