FDA.reportPublic FDA data

At Ease

Primary DI
00834533001490
Brand
At Ease
Company
AL-BAD MASSUOT YITZHAK LTD
Model
BCNAEZCSR02
Published
2020-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10834533000599PackageGS118In Commercial Distribution
00834533000592PrimaryGS10
00834533001490Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1083453300059910834533000599
00834533000592008345330005928345330005920834533000592
00834533001490008345330014908345330014900834533001490

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent underpadA flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence. It is intended to be used in the healthcare facility and in the home. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600487813
Device count
2
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
false
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
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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00199536910010BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910027BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910034BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910041BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910058BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910065BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910072BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910089BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910096BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910102BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910119BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910126BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911109BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911130BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911147BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911154BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911161BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
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