FDA UDI In Commercial Distribution 🇺🇸 United States

CheekZ

DI: 00860014032615 · Model: XL10 · ALOHA HOME HEALTH CARE SERVICES LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
CheekZ
Primary DI
00860014032615
Version / Model
XL10
Catalog Number
CHKZ-XL10
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
b0aadfb4-bb4d-46e4-ba03-e9e9ed6027a5

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 extra-large-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
EYQ Garment, Protective, For Incontinence

GMDN Terms

Code Name
11239 Adult nappy

Identifiers

Type ID
Primary 00860014032615
Package 00860014032646

Customer Contacts

Phone
+18586827178

Device Sizes

Type Value Unit Text
Circumference 46.5 Inch