FDA.reportPublic FDA data

Haenim

Primary DI
08809444071360
Brand
Haenim
Company
Haenim Co.,Ltd.
Model
HN-7X-WH-PK
Device description
This is powered breast pump to be used by lactating women to express and collect milk from their breasts.The final product is packed in a box with neccessary connecting parts including breast shield, head, membrane, tubing, backflowprotector,bottle, and instruction for use, so the user can use the device right after receving them.
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
K211016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211016000Powered Breast Pump (Models 7V and 7X)Haenim Co., Ltd.2022-06-29HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809444071360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809444071360088094440713608809444071360

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.

Contacts#

Phone, Email table
PhoneEmail
0323246614choi@stekorea.co.kr

Regulatory Flags#

DUNS number
688864716
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809444071049HaenimHN-7V-WH-GD2026-06-05
08809444071056HaenimHN-7V-WH-MB2026-06-05
08809444071223HaenimHN-7V-BK-MB2026-06-05
08809444071230HaenimHN-7V-BK-GD2026-06-05
08809444071339HaenimHN-7X-WH-GY2026-06-05
08809444071346HaenimHN-7X-WH-IV2026-06-05
08809444071353HaenimHN-7X-WH-PG2026-06-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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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