Duns Number:007941230
Device Description: Admissions Kit Custom For Southern Kentucky Rehab Hospital Wash Basin Denture Cup Mouthwas 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
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
ADKT204
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NSB
Product Code Name
Patient personal hygiene kit
Public Device Record Key
4a2d1799-3aa2-4033-842d-81e6b797239e
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
Package DI Number
20885632147422
Quantity per Package
8
Contains DI Package
10885632147425
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |