FDA.reportPublic FDA data

Little Martin's Drawer

Primary DI
00854878007056
Brand
Little Martin's Drawer
Company
EBZNS HOLDINGS LLC
Model
BBP1607
Device description
Single Breast Pump_Blue
Published
2017-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00854878007056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854878007056008548780070568548780070560854878007056

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
080521145
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854878007063Little Martin's DrawerBBP16072017-09-28
00854878007070Little Martin's DrawerBFD16092017-02-18
00854878007117Little Martin's DrawerBIT1611B2017-07-26
00854878007124Little Martin's DrawerBIT1611B2017-07-26
00854878007285Little Martin's DrawerBBP17052017-09-28
00854878007292Little Martin's DrawerBBP17052017-09-28
00854878007131Little Martin's DrawerBIT16112017-02-18

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