Hi bebe super - This electrical breast pump is an electrically - Bistos Co., Ltd.

Duns Number:689908411

Device Description: This electrical breast pump is an electrically powered, software-controlled breast pump in This electrical breast pump is an electrically powered, software-controlled breast pump intended to express and collect milk from the breast of lactating women. The breast pump system is comprised of a motor unit and pump kit including tubing.This electrical breast pump is intended to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). And this pump also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery.This electrical breast pump has two operating functions: basic massage/expression function and program function to save an operating sequence.

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More Product Details

Catalog Number

-

Brand Name

Hi bebe super

Version/Model Number

BT-150L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K200675,K200675

Product Code Details

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Device Record Status

Public Device Record Key

7e0877ae-c56f-4445-b28b-45000326b624

Public Version Date

June 16, 2021

Public Version Number

1

DI Record Publish Date

June 08, 2021

Additional Identifiers

Package DI Number

18800012315029

Quantity per Package

4

Contains DI Package

08800012315022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box

"BISTOS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 5