FDA.reportPublic FDA data

Wearever

Primary DI
00899624001650
Brand
Wearever
Company
PRIME LIFE FIBERS
Model
L123WHITEMED
Device description
Washable Reusable Women's Nylon and Lace Regular Absorbency Panty, WHT, MD
Published
2025-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Product Codes#

Code, Name table
CodeName
EYQGarment, Protective, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899624001650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899624001650008996240016508996240016500899624001650

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence pants, reusableAn underwear designed to retain urine leakage in incontinent adults and older children. It typically consists of a reusable man?s brief or woman?s panty with external softness and shape resembling regular underwear, and a disposable pant liner and/or a tube that deliver the urine to a bag placed on or around one leg. The device is typically used for patients with heavy urinary incontinence in healthcare facilities or at home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081030847
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
00810065846433WeareverHDL600-BGE-SM-EA2025-09-23
00810065846440WeareverHDL600-BGE-MD-EA2025-09-23
00810065846457WeareverHDL600-BGE-LG-EA2025-09-23
00810065846464WeareverHDL600-BGE-1X-EA2025-09-23
00810065846471WeareverHDL600-BGE-2X-EA2025-09-23
00810065846488WeareverHDL600-BGE-3X-EA2025-09-23
00813877010177WeareverM100WHITESM2025-09-23
00813877010184WeareverM100WHITEMED2025-09-23
00813877010191WeareverM100WHITELG2025-09-23
00813877010207WeareverM100WHITEXL2025-09-23
00813877010214WeareverM100WHITE2XL2025-09-23
00813877010221WeareverM100WHITE3XL2025-09-23
00813877010658WeareverMHD100WHTSM2025-09-23
00813877010665WeareverMHD100WHTMED2025-09-23
00813877010672WeareverMHD100WHTLG2025-09-23
00813877010689WeareverMHD100WHTXL2025-09-23
00813877010696WeareverMHD100WHT2XL2025-09-23
00813877010702WeareverLHD100WHTSM2025-09-23
00813877010719WeareverLHD100WHTMED2025-09-23
00813877010726WeareverLHD100WHTLG2025-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840330704813ProCureTwin Med, LLCEYQ2026-04-28
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96979303250023CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
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96979303250054CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
96979303250061CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
00199536911048BluelineTransparent Supply Solutions Ltd.EYQ2025-09-22
00199536911055BluelineTransparent Supply Solutions Ltd.EYQ2025-09-22
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