FDA.reportPublic FDA data

Wearever

Primary DI
00810065846464
Brand
Wearever
Company
PRIME LIFE FIBERS
Model
HDL600-BGE-1X-EA
Device description
Washable Reusable Women's Incontinence Bikini High Cut Maximum Absorbency Panty, BGE, 1X
Published
2025-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
false

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
00810065846464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810065846464008100658464648100658464640810065846464

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence pants, reusableAn underwear intended to help manage urine and/or stool leakage in incontinent adults and older children. It typically consists of a man’s brief or woman’s panty with external softness and shape resembling regular underwear; some types have a liner, or are designed with an integrated opening to allow the passage of stool into an disposable collection bag/pouch via a flange or noninvasive tube; the collection pouch may be supplied with the pants. The device is intended to be used by patients in healthcare facilities and at home or similar environment. This is a reusable device.

Regulatory Flags#

DUNS number
081030847
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
00810065846433WeareverHDL600-BGE-SM-EA2025-09-23
00810065846440WeareverHDL600-BGE-MD-EA2025-09-23
00810065846457WeareverHDL600-BGE-LG-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
00813877010733WeareverLHD100WHTXL2025-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810065846433WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846440WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846457WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846471WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846488WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010177WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010184WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010191WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010207WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010214WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010221WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010658WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010665WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010672WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010689WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010696WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010702WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010719WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010726WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010733WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010740WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011501WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011518WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011525WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011532WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011549WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011556WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011563WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011570WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011587WeareverPRIME LIFE FIBERSEYQ2025-09-23