FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 10885632147425
·
Model: ADKT204
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 10885632147425
- Version / Model
- ADKT204
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 1
- Public Version Date
- 2020-10-02
- Public Version Status
- New
- Public Device Record Key
- 4a2d1799-3aa2-4033-842d-81e6b797239e
Device Description
Admissions Kit Custom For Southern Kentucky Rehab Hospital Wash Basin Denture Cup Mouthwash Shampoo Facial Tissue Toothbrush Toothpaste Tumbler Washcloths Gait Belt Hand Lotion Deodorant 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 |
|---|---|---|---|---|
| NSB | Patient personal hygiene kit | Dental | 872.6855 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61949 | Personal care kit | A collection of devices intended to be used by a patient for personal care needs during a stay in a healthcare institution. It typically contains items such as gown, slippers, cap, hair comb and toothbrush in a storage bag, and may also contain additional personal care products e.g., toothpaste, lotion and deodorant. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20885632147422 | GS1 | 8 | In Commercial Distribution | ||
| Primary | 10885632147425 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid Freezing and Excessive Heat
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius