FDA.reportPublic FDA data

Wave, Collection Cups Kit

Primary DI
00810104130929
Brand
Wave, Collection Cups Kit
Company
WILLOW INNOVATIONS, INC.
Model
PMK20
Published
2025-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00810104130929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810104130929008101041309298101041309290810104130929

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

Regulatory Flags#

DUNS number
050917861
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060442520004ElvieEL01 - Celeste2018-05-03
00810104131247Wave, Collection Cups, Tubing and Diaphragm Set, RetailCCDT382026-01-28
00810104131261Wave, Collection Cups, 3pc Adapter Set, ReplacementCCAS392026-01-28
00810104130936 Wave Single Manual Pump KitPMK102025-07-23
00810104130943Willow Sync, Pump KitPEG252025-07-23
00810104130950Wave, Container 5oz, ReplacementRC05112025-07-23
00810104130967Wave, Gasket, 2 pack, RetailRG2P122025-07-23
00810104130974Wave, Flapper Valves, 4 pack, RetailRFL4132025-07-23
00810104130981Wave, Flange 24mm, ReplacementRF24142025-07-23
00810104130998Wave, Single, Tubing Set, RetailRSTS152025-07-23
00810104131001Wave, Handle, ReplacementRHR1162025-07-23
00810104130851Willow Go, 2 Splashguard Containers, 5ozL1GC052025-04-29
00810104130868Willow Go, 2 Splashguard Containers, 7ozL2GC072025-04-29
00810104130899Willow Go Splash Guard CCGSGR2025-04-29
00810104130790Silicone Wearable Breast PumpPP052025-04-28
00810104130875Willow Go, Replacement Container Bowl, 5ozR1GBR52025-04-28
00810104130882Willow Go, Replacement Container Bowl, 7ozR2GBR72025-04-28
05060442520561Elvie Pump Single AMZAEP01-01-N42025-02-11
05060442522077Elvie Stride 2EB01-212025-01-15
05060442522084Elvie Stride 2 Breast ShieldEB01-BS222025-01-15

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
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
00020451457666Pump In Style® Hands-free TubingMedela LLCOHH2023-07-26