FDA.reportPublic FDA data

Kendall

Primary DI
50192253040157
Brand
Kendall
Company
Cardinal Health 200, LLC
Model
9403
Catalog number
9403-
Device description
Hydrogel Breast Feeding Pad 3" (7.6 cm)
Published
2025-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
NAEDressing, wound, hydrogel without drug and/or biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30192253040153PackageGS12In Commercial Distribution
40192253040150PackageGS15In Commercial Distribution
50192253040157PackageGS15In Commercial Distribution
20192253040156PrimaryGS10
10192253040159Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3019225304015330192253040153
4019225304015040192253040150
5019225304015750192253040157
2019225304015620192253040156
1019225304015910192253040159

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975278040055vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040062vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040079vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040086vaginal pleasure liquibead/climax intense liquibeadJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040116vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
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06975278040130vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
00743537000449First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000715MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00860000562539LaviorLavior Pharma Inc.NAE2026-02-14
00860007877766LaviorLavior Pharma Inc.NAE2026-02-14
00860007877773LaviorLavior Pharma Inc.NAE2026-02-14
00860010195727LaviorLavior Pharma Inc.NAE2026-02-14
00860010195741LaviorLavior Pharma Inc.NAE2026-02-14
00850072068749CeladiaBiowound Solutions, Inc.NAE2025-12-18
06972864363031sknjxNingbo Chinmed Technology Co., Ltd.NAE2025-12-16
00197998326905Solventum™ Nu-Gel™Solventum US LLCNAE2025-09-22
00197998326981Solventum™ Nu-Gel™Solventum US LLCNAE2025-09-22
00858071004348Advanced Shield Hydrogel Silver Wound Barrier GEL, 2oz TubeKericure Inc.NAE2025-08-26
07290101428350Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDNAE2025-08-25
72901014283670Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDNAE2025-08-25
15056860000072Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000089Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
00858071004317Advanced Shield Chronic Wound Care, 2ozKericure Inc.NAE2025-08-08
00860000495097Altrazeal Transforming Powder DressingAltrazeal Life Sciences Inc.NAE2025-08-07
00858071004089Advanced Shield Max Silver BarrierKericure Inc.NAE2025-08-05