FDA.reportPublic FDA data

Medline

Primary DI
20197344025654
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS68020
Catalog number
MDS68020
Device description
PUMP,BREAST,MANUAL,KIT
Published
2024-01-04
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGYPUMP, BREAST, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGYPump, Breast, Non-PoweredObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344025654PackageGS124In Commercial Distribution
00197344025650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2019734402565420197344025654
00197344025650001973440256501973440256500197344025650

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, manualA hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810104130936 Wave Single Manual Pump KitWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130950Wave, Container 5oz, ReplacementWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130967Wave, Gasket, 2 pack, RetailWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130974Wave, Flapper Valves, 4 pack, RetailWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130981Wave, Flange 24mm, ReplacementWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130998Wave, Single, Tubing Set, RetailWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104131001Wave, Handle, ReplacementWILLOW INNOVATIONS, INC.HGY2025-07-23
00194346442294PARENT’S CHOICEWAL-MART STORES, INC.HGY2025-05-12
00810104130790Silicone Wearable Breast PumpExploramed NC7, Inc.HGY2025-04-28
09420060214017New Mum Premium Pack - Grey CapTHINK GREEN LIMITEDHGY2024-12-17
09420060214024New Mum Breastfeeding Essentials Pack - Grey CapTHINK GREEN LIMITEDHGY2024-12-17
09420060214031Gen. 2 Silicone Leakproof Pump & Ladybug Milk Collector Combo - 100ml Gen. 2 + 7THINK GREEN LIMITEDHGY2024-12-17
09420060214048Gen. 2 Silicone Leakproof Pump & Ladybug Milk Collector Combo - 150ml Gen. 2 + 7THINK GREEN LIMITEDHGY2024-12-17
09420060214109Silicone Pump & Milk Collector New Baby ComboTHINK GREEN LIMITEDHGY2024-12-17
09420060201314Gen. 1 Silicone Breast Pump & Cap Set - BlushTHINK GREEN LIMITEDHGY2024-12-12
09420060201420Gen. 3 Multifunctional Silicone Breast Pump & Silicone Cap - 160ml - Grey Ring -THINK GREEN LIMITEDHGY2024-12-12
09420060201437Gen. 3 Multifunctional Silicone Breast Pump & Silicone Cap - 160ml - Peach Ring THINK GREEN LIMITEDHGY2024-12-12
09420060201444Gen. 3 Multifunctional Silicone Breast Pump & Silicone Cap - 250ml - Grey Ring -THINK GREEN LIMITEDHGY2024-12-12
09420060201468New Mum Starter Pack (Non-Vent Cap)THINK GREEN LIMITEDHGY2024-12-12
09420060201475Gen. 3 Breast Pump FlangeTHINK GREEN LIMITEDHGY2024-12-12
09420060201482Gen. 3 Silicone Breast Pump & Bottle Top Set - 250ml - GreyTHINK GREEN LIMITEDHGY2024-12-12
09420060201505Gen. 3 Silicone Breast Pump & Bottle Top Set - 160ml - PeachTHINK GREEN LIMITEDHGY2024-12-12
09420060201512Gen. 3 Silicone Breast Pump & Attachments Combo - 160ml - GreyTHINK GREEN LIMITEDHGY2024-12-12
09420060201529Gen. 3 Silicone Breast Pump Starter Pack - GreyTHINK GREEN LIMITEDHGY2024-12-12
09420060201536Gen. 3 Silicone Breast Pump Starter Pack - PeachTHINK GREEN LIMITEDHGY2024-12-12
09420060201543Gen. 3 Multifunctional Silicone Breast Pump - 160ml - GreyTHINK GREEN LIMITEDHGY2024-12-12
09420060201550Gen. 3 Multifunctional Silicone Breast Pump - 160ml - PeachTHINK GREEN LIMITEDHGY2024-12-12
09420060201567Gen. 3 Multifunctional Silicone Breast Pump - 250ml - GreyTHINK GREEN LIMITEDHGY2024-12-12
09420060201574Gen. 3 Multifunctional Silicone Breast Pump - 250ml - PeachTHINK GREEN LIMITEDHGY2024-12-12
09420060214116Liquid Gold Collection SetTHINK GREEN LIMITEDHGY2024-12-12