FDA.reportPublic FDA data

QuickChange, 10 Count Pack

Primary DI
00861859000463
Brand
QuickChange, 10 Count Pack
Company
Ui Medical, LLC
Model
V 2.0
Device description
QuickChange for Male Incontinence, 10 Count Pack
Published
2023-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
00861859000463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861859000463008618590004638618590004630861859000463

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

Contacts#

Phone, Email table
PhoneEmail
475.226.8005hhc@uimed.com

Regulatory Flags#

DUNS number
080688136
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861859000425QuickChange, 25 count packV 2.02023-07-29
00861859000401QuickChange, 35 Count PackV 2.02023-07-26
00861859000456QuickChange, 8 count packV 2.02023-07-26
00861859000470QuickChange, 100 Count PackV 2.02023-07-26
00861859000487QuickChange, 50 count packV 2.02023-07-26

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
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96979303250023CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
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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