FDA.report

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
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EYQGarment, Protective, For Incontinence

Product Code Classifications

CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00861859000463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00861859000463008618590004638618590004630861859000463

GMDN Terms

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

Contacts

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 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 DIBrandCompanyProduct codePublished
05703538498749AbenaAbena North America, IncEYQ2026-02-18
05703538498800AbenaAbena North America, IncEYQ2026-02-18
05703538498862AbenaAbena North America, IncEYQ2026-02-18
05703538498886AbenaAbena North America, IncEYQ2026-02-18
96979303250009CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-13
96979303250016CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-13
96979303250047CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-13
05703538474811AbenaAbena North America, IncEYQ2025-11-17
05703538474835AbenaAbena North America, IncEYQ2025-11-17
05703538474859AbenaAbena North America, IncEYQ2025-11-17
00810065846433WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846440WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846457WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846464WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846471WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846488WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010177WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010184WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010191WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010207WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010214WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010221WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010658WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010665WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010672WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010689WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010696WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010702WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010719WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010726WeareverPRIME LIFE FIBERSEYQ2025-09-23