FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CheekZ
DI: 00199284989887
·
Model: M10-8
·
ALOHA HOME HEALTH CARE SERVICES LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CheekZ
- Primary DI
- 00199284989887
- Version / Model
- M10-8
- Catalog Number
- CHKZ-P-M10
- Company Name
- ALOHA HOME HEALTH CARE SERVICES LLC
- Labeler DUNS
- 096329705
- Distribution Status
- Not 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
- 36656cc7-6203-47c2-b520-88c426400068
- Distribution End Date
- 2025-06-27
Device Description
Adult Diapers Polybag – Medium, 8 Packs of 10 (Total 80 Diapers), Unisex, Waist 29–51 in
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 | 00199284989887 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 9 | Kilogram |