FDA.reportPublic FDA data

At Ease

Primary DI
00075289621710
Brand
At Ease
Company
AL-BAD MASSUOT YITZHAK LTD
Model
BUSAESUWS18
Published
2020-05-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
10075289621717PackageGS14Not in Commercial Distribution
00075289621710PrimaryGS10
00834533001742Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007528962171710075289621717
00075289621710000752896217100752896217100075289621710
00834533001742008345330017428345330017420834533001742

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence pants, single-useAn underwear designed to retain urine leakage in incontinent adults and older children. It typically consists of a single-use man?s brief or woman?s panty with external softness and shape resembling regular underwear, and an internal pad and/or isolated shell capable of retaining the urine of patients with light or medium incontinence while keeping the skin dry. The device is used in healthcare facilities or at home.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
600487813
Device count
18
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00834533009243TamponsBDOGR202016-09-20
00011822002769Rite Aid TamponsBRAGR202016-09-22
00011822012768Rite Aid TamponsBRAGR20+2016-09-22
00011822022774Rite Aid TamponsBRAGS182016-09-22
00011822022798Rite Aid TamponsBRAGP182016-09-22
00011822032773Rite Aid TamponsBRAGS18+2016-09-22
00011822032797Rite Aid TamponsBRAGP18+2016-09-22
00011822037259Rite Aid TamponsBRAXR182018-01-03
00011822105255Rite Aid TamponsBRAGS602016-09-22
00011822105354Rite Aid TamponsBRAGR632016-09-22
00011822214155Rite Aid TamponsBRAAC502016-09-22
00011822243742Rite Aid TamponsBRAAS402016-09-22
00011822435499Rite Aid TamponsBRAAGS40+2016-09-22
00011822493819Rite Aid TamponsBRAGR542016-09-22
00011822493826Rite Aid TamponsBRAGS502016-09-22
00011822543842Rite Aid TamponsBRAUR182016-09-22
00011822544139Rite Aid TamponsBRAUS182016-09-22
00011822583060Rite Aid TamponsBRAUC182016-09-22
00011822583077Rite Aid TamponsBRAUR362016-09-22
00011822616287Rite Aid TamponsBRAGP362016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840330704813ProCureTwin Med, LLCEYQ2026-04-28
10840330704820ProCureTwin Med, LLCEYQ2026-04-28
10840330704837ProCureTwin Med, LLCEYQ2026-04-28
96979303250023CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
96979303250030CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
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
00199536911062BluelineTransparent Supply Solutions Ltd.EYQ2025-09-22