FDA.reportPublic FDA data

Youha Powered breast pump

Primary DI
16957031400044
Brand
Youha Powered breast pump
Company
Ningbo Youhe Electrical Appliance Technology Co., Ltd
Model
YH-8015
Device description
The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. THE ONE, YH-8012, BB-5020 and YY-5030 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YY-8011 and YH-8019 have a single pumping configuration only. A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280 mmHg. The user interface for the THE ONE, YH-8012, BB-5020 and YY-5030 models consists of a front panel keypad and LCD display or LED display in which the user switches between modes and controls the vacuum pressure. The YY-5030 model does not have any visual indicators on the pump housing.
Published
2023-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HGXPump, Breast, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163136000Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd.2017-07-31HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16957031400044PackageGS112In Commercial Distribution
06957031400047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695703140004416957031400044
06957031400047069570314000476957031400047

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, electricA mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544407493
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16957031400013Youha Powered breast pumpYH-80042023-04-19
16957031400020Youha Powered breast pumpYH-80162023-04-19
16957031400037Youha Powered breast pumpYH-8006IV2023-04-19
16957031400051Youha Powered breast pumpTHEONE2023-04-19
16957031400068Youha Powered breast pumpYH-80112023-04-19
16957031400075Youha Powered breast pumpYH- 80122023-04-19
16957031400082Youha Powered breast pumpYH-80192023-04-19
16957031400099Bebebao Powered breast pumpBB-50202023-04-19
16957031400105Yiyadodo Powered breast pumpYY-50302023-04-19

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