FDA.reportPublic FDA data

Ameda ComfortGel Hydrogel Pads

Primary DI
04719745091568
Brand
Ameda ComfortGel Hydrogel Pads
Company
BENQ MATERIALS CORP.
Model
17261M
Device description
Soothes, cools and helps with tender sore nipples. Immediate relief on contact
Published
2025-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
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
04719745091568PrimaryGS10
14719745091565Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719745091568047197450915684719745091568
1471974509156514719745091565

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
657476292
Device count
2
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719745027055DermaAngel Acne patchAP-362-c2022-09-21
04719745040429DermaAngel Acne patchAP-361-42022-09-21
04719745053085DermaAngel Acne patchAP-341-52022-09-21
04719745053580DermaAngel Acne patchAP-3c1-j2022-09-21
04719745072628DermaAngel Acne patchAP-361-62022-09-21
04719745108518DermaAngel Active Patch Original AP-361-82022-09-21
04719745108525DermaAngel Active Patch Original AP-391-j2022-09-21
04719745108532DermaAngel Active Patch Original AP-391-82022-09-21
04719745108549DermaAngel Active Patch IntensiveAP-SA151-f2022-09-21
04719745108556DermaAngel Active Patch IntensiveAP-SA151-p2022-09-21
04719745077562DermaAngel Clear Patch OriginalAP-361-c2023-10-11
04719745106682DermaAngel Clear Patch IntensiveAP-SA151-82025-06-24
04719745091551DermaAngel Clear Patch IntensiveAP-SA1i1-s2024-08-06
04719745053450DermaAngel Clear Patch OriginalAP-361-32024-07-08
04719745073793DermaAngel Clear Patch IntensiveAP-SA151-62024-07-08
04719745088803DermaAngel Clear Patch IntensiveAP-SA1i1-t2024-07-08
04719745088810DermaAngel Clear Patch IntensiveAP-SA1l1-f2024-07-08
04719745088827DermaAngel Clear Patch IntensiveAP-SA1y1-h2024-07-08
04719745074158DermaAngel Clear Patch IntensiveAP-SA101-22024-06-04
04719745086168DermaAngel Clear Patch OriginalAP-361-42024-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975983272505MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.NTC2024-05-23
06975983272512MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.NTC2024-05-23
00810104130738Gel PackWILLOW INNOVATIONS, INC.NTC2024-02-14
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