FDA.reportPublic FDA data

Breast Pump Kit with Harmony & 80mL container

Primary DI
20020451464477
Brand
Breast Pump Kit with Harmony & 80mL container
Company
MEDELA, INC.
Model
101046447
Published
2024-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHHBreast Pump Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHHBreast Pump KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20020451464477PackageGS110In Commercial Distribution
00020451464473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2002045146447720020451464477
00020451464473000204514644730204514644730020451464473

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump support kit, reusableA collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-435-8316customer.service@medela.com

Regulatory Flags#

DUNS number
052002029
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
true
Expiration date on label
true
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
2002045146457618mm PersonalFit™ Plus Breast shields1010464572024-05-21
10020451416240Solo™1010416242024-05-15
10020451467099Swing Maxi™ Hands-free1010467092024-05-14
20020451463623Pediatric Breast Pump Kit with Harmony1010463622024-05-08
20020451101303ENFit Syringe 1mlENF01LD1010331592024-05-06
20020451100603Enteral FeedingENPU-16-402016-09-22
20020451331083Enteral FeedingENPU16402017-12-20
10020451101719Enteral FeedingENFDUALCAPCNSLD2017-01-27
20020451100894Enteral FeedingINT-CAP2016-09-22
20020451101181Enteral FeedingTL-CAP2016-09-22
10020451101467Enteral FeedingENFMEDCAPNSLD2016-09-22
20020451101709Enteral FeedingENFDUALCAPCLD2017-01-27
00020451463445Colostrum Protector1010463442023-11-01
20020451457837Hands-free Breast shields, 27mm1010457832023-10-30
20020451101402Enteral FeedingENFCAPLD2016-09-22
20020451101419Enteral FeedingENFDUALCAPLD2016-09-22
10020451101429Enteral FeedingENFDUALCAPNSLD2016-09-22
20020451101433Enteral FeedingENFFEMALELD2016-09-22
20020451101440Enteral FeedingENFMALELD2016-09-22
20020451101457Enteral FeedingENFMEDCAPLD2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00020451905389MedelaGuangdong Youmeng Electrical Technology Co., Ltd.OHH2026-03-20
01220000280335Motion InBra™ Double Pumping setMedela LLCOHH2026-03-10
01220000280342Motion InBra™ Single Pumping setMedela LLCOHH2026-03-10
01220000280731Motion InBra™ Double Pumping setMedela LLCOHH2026-03-10
01220000280748Motion InBra™ Single Pumping setMedela LLCOHH2026-03-10
00810104131247Wave, Collection Cups, Tubing and Diaphragm Set, RetailWILLOW INNOVATIONS, INC.OHH2026-01-28
00810104131261Wave, Collection Cups, 3pc Adapter Set, ReplacementWILLOW INNOVATIONS, INC.OHH2026-01-28
00810104130929Wave, Collection Cups KitWILLOW INNOVATIONS, INC.OHH2025-12-17
00020451472928Resupply Kit Swing Maxi/Freestyle Hands-free PumpMedela LLCOHH2025-01-17
00020451472935Resupply Kit Swing Maxi/Freestyle Hands-free PumpMedela LLCOHH2025-01-17
00020451472942Resupply Kit Swing Maxi/Freestyle Hands-free PumpMedela LLCOHH2025-01-17
00020451468723Pump In Style® Hands-free Resupply KitMedela LLCOHH2024-07-15
00020451468730Pump In Style® Hands-free Resupply KitMedela LLCOHH2024-07-15
00020451468747Pump In Style® Hands-free Resupply KitMedela LLCOHH2024-07-15
0002045146457218mm PersonalFit™ Plus Breast shieldsMedela LLCOHH2024-05-21
2002045146457618mm PersonalFit™ Plus Breast shieldsMEDELA, INC.OHH2024-05-21
1002045146456218mm PersonalFit™ Plus Breast shieldsMedela LLCOHH2024-05-21
10020451464586PNSMX Resupply kitsMedela LLCOHH2024-05-21
00020451463629Pediatric Breast Pump Kit with HarmonyMedela LLCOHH2024-05-08
00020451464473Breast Pump Kit with Harmony & 80mL containerMedela LLCOHH2024-05-08
20020451463623Pediatric Breast Pump Kit with HarmonyMEDELA, INC.OHH2024-05-08
20020451463449Colostrum ProtectorMedela LLCOHH2023-11-01
00020451463445Colostrum ProtectorMEDELA, INC.OHH2023-11-01
00020451457833Hands-free Breast shields, 27mmMedela LLCOHH2023-10-30
20020451457837Hands-free Breast shields, 27mmMEDELA, INC.OHH2023-10-30
00020451458519PersonalFit Flex™ Double Pumping KitMedela LLCOHH2023-08-18
00020451458533PersonalFit Flex™ Double Pumping KitMedela LLCOHH2023-08-18
20020451458513PersonalFit Flex™ Double Pumping KitMEDELA, INC.OHH2023-08-18
20020451458537PersonalFit Flex™ Double Pumping KitMEDELA, INC.OHH2023-08-18
00020451457666Pump In Style® Hands-free TubingMedela LLCOHH2023-07-26