FDA.reportPublic FDA data

Caroli

Primary DI
04009408027141
Brand
Caroli
Company
Curatex GmbH
Model
pants XL
Device description
Caroli Incontinence Underwear Super Extra Large (XL)
Published
2020-09-08
Public version status
New
Distribution status
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
04000576037994PackageGS110In Commercial Distribution
04009408027141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04000576037994040005760379944000576037994
04009408027141040094080271414009408027141

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence pants linerA disposable pad composed of absorbent materials that is worn inside incontinence pants to catch and retain urine from an incontinent person. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316433234
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04009408026953CaroliNormal2020-09-08
04009408026991Carolinormal2020-09-08
04009408027011Caroliextra2020-09-08
04009408027035Caroliextra plus2020-09-08
04009408027042Carolimini plus2020-09-08
04009408027066Carolimaxi plus2020-09-08
04009408027080Carolipants medium2020-09-08
04009408027097Carolipants discreet medium2020-09-08
04009408027110Carolipants large2020-09-08
04009408027127Carolipants discreet large2020-09-08
04009408027134Carolipants couture large2020-09-08
04009408027158Carolipants XXL2020-09-08
04009408027196ASSUREDextra2020-04-15
04009408027202ASSUREDnormal2020-04-15
00000020100674ASSUREDnormal2020-04-15
04000576013882ASSUREDextra2020-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226441224SuresVIVE HEALTH LLCEYQ2026-07-21
00810226441231SuresVIVE HEALTH LLCEYQ2026-07-21
00810226441248SuresVIVE HEALTH LLCEYQ2026-07-21
00810178889334SuresVIVE HEALTH LLCEYQ2026-07-17
00810178889341SuresVIVE HEALTH LLCEYQ2026-07-17
00810178889358SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441156SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441163SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441170SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441187SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441194SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441200SuresVIVE HEALTH LLCEYQ2026-07-17
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
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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