FDA.reportPublic FDA data

Wave, Collection Cups, Tubing and Diaphragm Set, Retail

Primary DI
00810104131247
Brand
Wave, Collection Cups, Tubing and Diaphragm Set, Retail
Company
WILLOW INNOVATIONS, INC.
Model
CCDT38
Published
2026-01-28
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
00810104131247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810104131247008101041312478101041312470810104131247

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
00810104131261Wave, Collection Cups, 3pc Adapter Set, ReplacementCCAS392026-01-28
00810104130929Wave, Collection Cups KitPMK202025-12-17
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
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
00020451457666Pump In Style® Hands-free TubingMedela LLCOHH2023-07-26