CheekZ

Basic Information

• Brand Name: CheekZ
• Primary DI: 00860014032684
• Version / Model: M10
• Catalog Number: CHKZ-M10
• Company Name: ALOHA HOME HEALTH CARE SERVICES LLC
• Labeler DUNS: 096329705
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-27
• Public Version: 1
• Public Version Date: 2025-07-07
• Public Version Status: New
• Public Device Record Key: c957bbf7-f441-49e6-92d2-a7b4600f189f

Device Description

Disposable adult diapers made with non-woven fabric, wood pulp, super absorbent polymer (SAP), and breathable PE film. Features include leak guards, odor control, and soft top sheet. Pack of 10 medium-sized pieces.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	876.5920	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11239	Adult nappy	A disposable undergarment (a nappy or diaper) composed of absorbent material and worn between the legs used to collect urine and faeces from an incontinent adult patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860014032684	GS1
Package	00860014032622	GS1	Inner Pack	8	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Circumference	40	Inch