FDA.reportPublic FDA data

Capable

Primary DI
06975867555229
Brand
Capable
Company
Shanghai Kabu International Trade Co., Ltd
Model
Size 4
Published
2023-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
16975867555226PackageGS1102In Commercial Distribution
06975867555229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697586755522616975867555226
06975867555229069758675552296975867555229

GMDN Terms#

Term, Definition table
TermDefinition
Infant nappyA disposable undergarment (nappy or diaper) composed of absorbent material intended to be worn around the perineum between the legs to collect urine and faeces for disposal from an infant or an incontinent child. This is a single-use device.

Regulatory Flags#

DUNS number
416421979
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975867555236CapableSize 32023-02-24
06975867555243CapableSize 22023-02-24
06975867555250CapableSize 12023-02-24
06975867555267CapableSize N2023-02-24
06975867555274CapableSize 4T-5T2023-02-24
06975867555281CapableSize 3T-4T2023-02-24
06975867555298CapableSize 2T-3T2023-02-24
06975867555212Capablesize 52023-02-24
16975867555226CapableSize 42023-02-24
16975867555233CapableSize 32023-02-24
16975867555240CapableSize 22023-02-24
16975867555257CapableSize 12023-02-24
16975867555264CapableSize N2023-02-24
16975867555271CapableSize 4T-5T2023-02-24
16975867555288CapableSize 3T-4T2023-02-24
16975867555295CapableSize 2T-3T2023-02-24
06975867555205CapableSize 62023-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536910003BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
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