FDA.reportPublic FDA data

The First Years

Primary DI
B268Y62280
Brand
The First Years
Company
TOMY INTERNATIONAL, INC.
Model
Y6228
Device description
Quiet Expressions breast pump with Breastflow bottle
Published
2017-02-11
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B268Y62281PackageHIBCC1Not in Commercial Distribution
B268Y62280PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
065183758
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B268L274120LAMAZE/JOHN DEEREL27412L274122019-09-23
B268Y7078A80The First YearsY7078A8Y7078A82025-09-22
B268Y7078A81The First YearsY7078A8Y7078A82025-09-22
B26879570The First YearsY7957Y79572024-01-18
B268L276190LamazeL27619L276192018-07-01
B268Y108960American Red CrossY10896Y108962017-11-13
B268Y5288L0LamazeY5228L2019-10-11
B268Y60530The First YearsY60532017-02-11
B268Y7054Y70570American Red CrossY7054, Y7057Y70572017-12-29
B268Y7054Y705701American Red CrossY7054Y70542017-12-20
B268Y70780American Red CrossY70782016-09-23
B268Y71490American Red CrossY71492017-05-29
B268Y77900American Red CrossY7790Y77902017-11-15
B268Y79160American Red CrossY7916Y79162022-03-31
B268Y78251American Red CrossY7825Y7825A12019-11-04
B268Y52880The First YearsY52882017-02-11
B268Y7078A70The First YearsY7078A7Y7078A72024-03-25
B268Y7078A71The First YearsY7078A7Y7078A72024-03-25
B268Y79571The First YearsY7957Y79572024-01-18
B268Y7057A51The First YearsY7057A5Y7057A52024-01-12

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Primary DI, Brand, Company table
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07640108055941Breast shell sterile DeTach 14 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055965Breast shell sterile DeTach 15 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055989Breast shell sterile DeTach 16 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108056009Breast shell sterile DeTach 17 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055545Breast shell sterile DeTach 18 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055569Breast shell sterile DeTach 21 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055583Breast shell sterile DeTach 24 mm (2 pcs)Ardo medical AGHGX2026-07-30
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