Ameda

FDA UDI

Class I (US FDA UDI)

by Ameda, Inc.

Identity

Trade Name: Ameda FDA UDI
Generic Name: Breast pump support kit, reusable FDA UDI
Device Name: Dual milk collection system FDA UDI
Model / Reference: True Protect FDA UDI
Description: Dual milk collection system FDA UDI

Identifiers

Catalog Number: 18001 FDA UDI
Primary DI / UDI-DI: 00810725025826 FDA UDI
FDA Product Code: HGY FDA UDI
GMDN Term: Breast pump support kit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.5150 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

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Breast pump support kit, reusable

Ameda by Ameda, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Breast pump support kit, reusable.

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Spectra — Uzinmedicare Co., Ltd. · Class II
Unimom — Unimom.Co · Class II
PNSMX Resupply kits — Medela LLC · Class II
Hands-free Breast shields, 24mm — Medela LLC · Class II
Spectra — Uzinmedicare Co., Ltd. · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Ameda, Inc.

Sources (1)

FDA UDI d14cf43f-af33-4104-87c4-10699c22d7f5 35 fields · synced Jun 8, 2026