FDA UDI
In Commercial Distribution
🇺🇸 United States
Scrub Care Exidine
DI: 10885403192821
·
Model: CLEAN1
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Scrub Care Exidine
- Primary DI
- 10885403192821
- Version / Model
- CLEAN1
- Catalog Number
- CLEAN1
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-02
- Public Version
- 3
- Public Version Date
- 2024-02-23
- Public Version Status
- Update
- Public Device Record Key
- 957ebea9-29e3-443c-a638-8a34ba78e733
- Distribution End Date
- 2024-03-31
Device Description
Scrub Care Exidine-4 CHG 4%, Chlorhexidine Gluconate 4% Solution
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| OJU | Skin prep tray | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35246 | Surgical patient preparation kit | A collection of devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403192829 | GS1 | Case | 3 | In Commercial Distribution | 2024-03-31 |
| Package | 20885403192828 | GS1 | Pack | 10 | In Commercial Distribution | 2024-03-31 |
| Primary | 10885403192821 | GS1 |
Customer Contacts
- Phone
- +1(800)523-0502
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius