FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 10885632078835
·
Model: ARW100
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 10885632078835
- Version / Model
- ARW100
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-21
- Public Version
- 1
- Public Version Date
- 2020-09-29
- Public Version Status
- New
- Public Device Record Key
- 386c8a1d-7e21-46f8-bb03-c237ee43adf9
Device Description
Adhesive Remover Wipe Non-sterile Contains Isopropyl Alcohol 1.15 X 2.75 Disposable/sngle Use Not Nat Rubber Ltx Non Sterile MediChoice
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
- 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
- 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 |
|---|---|---|---|---|
| KOX | SOLVENT, ADHESIVE TAPE | General, Plastic Surgery | 878.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60494 | Patient medical adhesive remover | A liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30885632078839 | GS1 | 100 | In Commercial Distribution | ||
| Primary | 10885632078835 | GS1 | ||||
| Package | 20885632078832 | GS1 | 10 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from heat, flame and other ignition sources. Store at room temperature
- Type
- Special Storage Condition, Specify