FDA.reportPublic FDA data

Gel Pack

Primary DI
00810104130738
Brand
Gel Pack
Company
WILLOW INNOVATIONS, INC.
Model
GP2312
Device description
Gel Nipple Pads (900-00135)
Published
2024-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NTCNursing Pad, Hydrogel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTCNursing Pad, HydrogelGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810104130738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810104130738008101041307388101041307380810104130738

GMDN Terms#

Term, Definition table
TermDefinition
Nipple pad/ring, single-useA device intended to be worn directly over the breast/nipple of a nursing woman between breast feedings to help protect the nipple from chafing, due to friction from clothing, and/or to treat sore/cracked nipples; it may also be intended to absorb leaking breast milk. It may be in the form of a fabric or cotton pad (commonly known as a nursing pad), a dome-shaped gel (e.g., hydrogel) cover, or a ring. This is a single-use 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719745091568Ameda ComfortGel Hydrogel PadsBENQ MATERIALS CORP.NTC2025-01-21
06975983272505MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.NTC2024-05-23
06975983272512MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.NTC2024-05-23
00081010413073Gel PackEXPLORAMED NC7, INC.NTC2024-02-14
06975983272031MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.NTC2023-11-08
05010058088832InstrapacROBINSON HEALTHCARE LIMITEDNTC2023-08-08
05010058188839InstrapacROBINSON HEALTHCARE LIMITEDNTC2023-08-08