FDA UDI
In Commercial Distribution
🇺🇸 United States
Clever Choice
DI: 00898302140070
·
Model: SDI-ADL
·
SIMPLE DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Clever Choice
- Primary DI
- 00898302140070
- Version / Model
- SDI-ADL
- Catalog Number
- 98302-0140-07
- Company Name
- SIMPLE DIAGNOSTICS INC
- Labeler DUNS
- 004135503
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-01-05
- Public Version
- 1
- Public Version Date
- 2021-01-13
- Public Version Status
- New
- Public Device Record Key
- 254eaf25-b303-4084-a76a-b6b8a24f5e67
Device Description
Clever Choice Comfort Protect Adult Diapers - large
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 20898302140074 | GS1 | ||||
| Primary | 00898302140070 | GS1 | ||||
| Package | 10898302140077 | GS1 | Case | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 1.877.342.2385
- [email protected]