FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sure Care
DI: 10884527022007
·
Model: 1110B
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- Sure Care
- Primary DI
- 10884527022007
- Version / Model
- 1110B
- Catalog Number
- 1110B
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2018-06-22
- Public Version
- 4
- Public Version Date
- 2023-07-03
- Public Version Status
- Update
- Public Device Record Key
- 1afada2e-6d56-4a4d-8e7e-52c6654e941c
- Distribution End Date
- 2023-07-01
Device Description
Bladder Control Pads,Moderate
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
- 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
- No
- 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 |
|---|---|---|---|---|
| 35817 | Incontinence pants liner | A disposable pad composed of absorbent materials that is worn inside incontinence pants to catch and retain urine from an incontinent person. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884527022004 | GS1 | CASE | 120 | Not in Commercial Distribution | 2023-07-01 |
| Primary | 10884527022007 | GS1 | ||||
| Unit of Use | 30884527022001 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10.75 | Inch | |
| Width | 4 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ;