FDA.reportPublic FDA data

Symphony & Harmony Double Duet Breast pump kit-Sterile

Primary DI
10020451671151
Brand
Symphony & Harmony Double Duet Breast pump kit-Sterile
Company
Medela LLC
Model
67115S
Device description
Breast pump kit
Published
2016-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

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
10020451671151PackageGS110In Commercial Distribution
00020451671154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002045167115110020451671151
00020451671154000204516711540204516711540020451671154

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump support kit, single-useA 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 milk collection containers (e.g., bottle, cup). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004358316customer.service@medela.com

Regulatory Flags#

DUNS number
052002029
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00020451904870Freestyle™ Mini Hands-free1010483952026-05-01
01220000280335Motion InBra™ Double Pumping set1010476012026-03-10
01220000280342Motion InBra™ Single Pumping set1010476022026-03-10
01220000280731Motion InBra™ Double Pumping set1010476012026-03-10
01220000280748Motion InBra™ Single Pumping set1010476022026-03-10
00020451903873Motion InBra™1010475542026-02-16
00020451903880Motion InBra™1010475552026-02-16
00020451904566Motion InBra™1010475542026-02-16
00020451904573Motion InBra™1010475552026-02-16
00020451470917Pump In Style® Pro+1010470912026-01-28
00020451470924Pump In Style® Pro+ Hands-free1010470922026-01-28
00020451473390Pump In Style® Pro+ Bundle1010473392026-01-28
10020451470914Pump In Style® Pro+1010470912026-01-28
10020451470921Pump In Style® Pro+ Hands-free1010470922026-01-28
10020451473397Pump In Style® Pro+ Bundle1010473392026-01-28
00020451100890Enteral FeedingINT-CAP2016-09-22
00020451101187Enteral FeedingTL-CAP2016-09-22
00020451332123Enteral FeedingTLCAP2018-02-22
00020451904160Pump In Style® Pro Bundle1010477182025-06-10
00020451904177Pump In Style® Pro Bundle1010477182025-06-10

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
20020451464477Breast Pump Kit with Harmony & 80mL containerMEDELA, 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