FDA.reportPublic FDA data

Elvie Nipple Cushion

Primary DI
05060442521766
Brand
Elvie Nipple Cushion
Company
WILLOW INNOVATIONS, INC.
Model
ACCS-NCM02
Device description
Pair of Nipple Cushions, 17 mm
Published
2023-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PWABreast Pump Accessory, Milk Expression Aid, Via Positive Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWABreast Pump Accessory, Milk Expression Aid, Via Positive PressureObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060442521766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060442521766050604425217665060442521766

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

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
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

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Primary DI, Brand, Company table
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09420060203059Ladybug Silicone Breast Milk Collectors (40ml) - 2pcsTHINK GREEN LIMITEDPWA2024-12-17
09420060203066Ladybug Silicone Breast Milk Collector - 40mlTHINK GREEN LIMITEDPWA2024-12-17
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09420060204032Silicone Colostrum Collector (pre-sterilised) - 20ml - 1pcTHINK GREEN LIMITEDPWA2024-12-17
09420060204049Silicone Colostrum Collector (pre-sterilised) - 20ml - 2pcsTHINK GREEN LIMITEDPWA2024-12-17
09420060204056Silicone Colostrum Collector Pack (pre-sterilised) - 6pcsTHINK GREEN LIMITEDPWA2024-12-17
09420060204063Silicone Colostrum Collector Pack (pre-sterilised) - 12pcsTHINK GREEN LIMITEDPWA2024-12-17
09420060204070Multi-size Silicone Colostrum Collector Pack (pre-sterilised) - 20ml*1+4ml*4THINK GREEN LIMITEDPWA2024-12-17
19420060204084Silicone Colostrum Collector 50pc Bulk Pack (pre-sterilised) THINK GREEN LIMITEDPWA2024-12-17
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