QuickChange, 8 count pack

Primary DI
00861859000456
Brand
QuickChange, 8 count pack
Company
Ui Medical, LLC
Model
V 2.0
Device description
QuickChange for Male Incontinence, 8 Count Pack
Published
2023-07-26
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

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
00861859000456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861859000456008618590004568618590004560861859000456

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
00861859000425QuickChange, 25 count packV 2.02023-07-29
00861859000401QuickChange, 35 Count PackV 2.02023-07-26
00861859000463QuickChange, 10 Count PackV 2.02023-07-26
00861859000470QuickChange, 100 Count PackV 2.02023-07-26
00861859000487QuickChange, 50 count packV 2.02023-07-26

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05703538474811AbenaAbena North America, IncEYQ2025-11-17
05703538474835AbenaAbena North America, IncEYQ2025-11-17
05703538474859AbenaAbena North America, IncEYQ2025-11-17
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