FDA.report

Medline

Primary DI
10197344006205
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS68107
Catalog number
MDS68107
Device description
DIAPHRAGMS,BREAST PUMP,2PCS
Published
2023-04-12
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
true

Related Records

Contact Domains

Product Codes

CodeName
HGXPUMP, BREAST, POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10197344006205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019734400620510197344006205

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
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04897152760038eufy Wearable Breast Pump S1Anker Innovations LimitedHGX2026-03-13
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