FDA.report

Syphony Breat pump kit- Sterile

Primary DI
00020451673998
Brand
Syphony Breat pump kit- Sterile
Company
Medela LLC
Model
67399S
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

Related Records

Contact Domains

Product Codes

CodeName
OHHBreast Pump Kit

Product Code Classifications

CodeDeviceSpecialtyClass
OHHBreast Pump KitObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20020451673992PackageGS110In Commercial Distribution
00020451673998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2002045167399220020451673992
00020451673998000204516739980204516739980020451673998

GMDN Terms

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

Contacts

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 DIBrandModelCatalogPublished
01220000280731Motion InBra™ Double Pumping set1010476012026-03-10
01220000280748Motion InBra™ Single Pumping set1010476022026-03-10
00020451904566Motion InBra™1010475542026-02-16
00020451904573Motion InBra™1010475552026-02-16
10020451470914Pump In Style® Pro+1010470912026-01-28
10020451470921Pump In Style® Pro+ Hands-free1010470922026-01-28
10020451473397Pump In Style® Pro+ Bundle1010473392026-01-28
00020451904177Pump In Style® Pro Bundle1010477182025-06-10
00020451470900Pump In Style® Pro 1010470902025-06-09
10020451470938Pump In Style® Pro1010470932025-06-09
07612367089470Solo™ Hands-free1010473092025-05-09
10020451456703Duo Hands-free1010456702025-03-31
00020451000411Symphony Single Kit-Sterile67026S2016-12-12
20020451100047Enteral FeedingEB-060-142016-09-22
20020451100054Enteral FeedingEB-060-152016-09-22
20020451100061Enteral FeedingEB-060-162016-09-22
20020451100078Enteral FeedingEB-060-182016-09-22
20020451100085Enteral FeedingEB-060-1822016-09-22
20020451100092Enteral FeedingEB-060-192016-09-22
20020451100108Enteral FeedingEB-060-1922016-09-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00020451905389MedelaGuangdong Youmeng Electrical Technology Co., Ltd.OHH2026-03-20
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
00020451468723Pump In Style® Hands-free Resupply KitMEDELA, INC.OHH2024-07-15
00020451468730Pump In Style® Hands-free Resupply KitMEDELA, INC.OHH2024-07-15
00020451468747Pump In Style® Hands-free Resupply KitMEDELA, INC.OHH2024-07-15
2002045146457618mm PersonalFit™ Plus Breast shieldsMEDELA, INC.OHH2024-05-21
1002045146456218mm PersonalFit™ Plus Breast shieldsMEDELA, INC.OHH2024-05-21
10020451464586PNSMX Resupply kitsMEDELA, INC.OHH2024-05-21
20020451463623Pediatric Breast Pump Kit with HarmonyMEDELA, INC.OHH2024-05-08
20020451464477Breast Pump Kit with Harmony & 80mL containerMEDELA, INC.OHH2024-05-08
00020451463445Colostrum ProtectorMEDELA, INC.OHH2023-11-01
20020451457837Hands-free Breast shields, 27mmMEDELA, INC.OHH2023-10-30
20020451458513PersonalFit Flex™ Double Pumping KitMEDELA, INC.OHH2023-08-18
20020451458537PersonalFit Flex™ Double Pumping KitMEDELA, INC.OHH2023-08-18
00020451457666Pump In Style® Hands-free TubingMEDELA, INC.OHH2023-07-26
00020451456713Hands-free Collection CupsMEDELA, INC.OHH2023-06-12
20020451457813Hands-free Breast shields, 21mmMEDELA, INC.OHH2023-06-12
20020451457820Hands-free Breast shields, 24mmMEDELA, INC.OHH2023-06-12
20020451457844Hands-free MembranesMEDELA, INC.OHH2023-06-12
20020451457851Hands-free O-ringsMEDELA, INC.OHH2023-06-12
20020451457868Hands-free TubingMEDELA, INC.OHH2023-06-12
05060442521544Elvie Pump KitCHIARO TECHNOLOGY LIMITEDOHH2023-03-07
2002045128972835 mL Breast Milk Collection & Storage ContainerMEDELA, INC.OHH2023-03-06
10020451446599Colostrum Collector Sterile MEDELA, INC.OHH2022-10-03
10020451447442Symphony® Breast Pump Kit with Colostrum CollectorMEDELA, INC.OHH2022-10-03
00020451452302PNSMX Resupply kitsMEDELA, INC.OHH2022-09-19