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Duo Double Electric Breast Pump

FDA UDI

Class II (US FDA UDI)

by Bistos Co., Ltd.

Identity

Trade Name
Duo Double Electric Breast Pump FDA UDI
Generic Name
Breast pump, electric FDA UDI
Device Name
The Duo Double Electric Breast Pump is a single user, double electric breast pump that includes customizable massage and expression modes and is capable of single and double pumping. FDA UDI
Model / Reference
MD-20.2 FDA UDI
Description
The Duo Double Electric Breast Pump is a single user, double electric breast pump that includes customizable massage and expression modes and is capable of single and double pumping. FDA UDI

Identifiers

Primary DI / UDI-DI
00887529000151 FDA UDI
510(k) Number
K160274 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Breast pump, electric

Duo Double Electric Breast Pump by Bistos Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Breast pump, electric.

Cleared under the same submission

K160274 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bistos Co., Ltd.

Sources (1)

  • FDA UDI 6b85cd20-5e7c-4829-9e6a-55ac8d5f8a92 35 fields · synced May 30, 2026