Ameda, Inc.

FDA UDI

Class I (US FDA UDI)

by Ameda, Inc.

Identity

Trade Name: Ameda, Inc. FDA UDI
Generic Name: Breast pump, manual FDA UDI
Device Name: Breast Pumping Starter Kit FDA UDI
Model / Reference: 17069P FDA UDI
Description: Breast Pumping Starter Kit FDA UDI

Identifiers

Catalog Number: 17069P FDA UDI
Primary DI / UDI-DI: 00810725020654 FDA UDI
510(k) Number: K912355 FDA UDI
FDA Product Code: HGY FDA UDI
GMDN Term: Breast pump, manual 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

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Breast pump, manual

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

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Cleared under the same submission

K912355 also covers:

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 5ae6554e-2929-4578-a3c3-b701a2498313 37 fields · synced May 30, 2026