Elvie Pump Double

FDA UDI

Class II (US FDA UDI)

by Willow Innovations, Inc.

Identity

Trade Name: Elvie Pump Double FDA UDI
Generic Name: Breast pump, electric FDA UDI
Device Name: Breast pump, powered FDA UDI
Model / Reference: EP01-02-M-AMZ FDA UDI
Description: Breast pump, powered FDA UDI

Identifiers

Primary DI / UDI-DI: 05060442521797 FDA UDI
510(k) Number: K181863 FDA UDI
FDA Product Code: HGX FDA UDI
GMDN Term: Breast pump, electric FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.5160 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Breast pump, electric

Elvie Pump Double by Willow Innovations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K181863 also covers:

Elvie Pump Single AMZA — WILLOW INNOVATIONS, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Willow Innovations, Inc.

Sources (1)

FDA UDI 3d6b9780-6d2f-43f6-9768-b9eb61ae9562 34 fields · synced Jun 8, 2026