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 | 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 | 00860014032615 | GS1 | ||||
| Package | 00860014032646 | GS1 | Inner Pack | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- +18586827178
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Circumference | 46.5 | Inch |