Duns Number:800149346
Device Description: Kit to assist with basic Body Fluids cleanup intended for use at general workplaces, typic Kit to assist with basic Body Fluids cleanup intended for use at general workplaces, typically accompanying first aid kits for spilled blood or other bodily fluids. Managed First Aid.
Catalog Number
0102074
Brand Name
Redicare
Version/Model Number
Bodily Fluid Cleanup Kit
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OKG
Product Code Name
Body Fluid Clean Up Kit
Public Device Record Key
eb183ed2-a19b-4d18-b613-7b78a4d338fa
Public Version Date
August 05, 2020
Public Version Number
1
DI Record Publish Date
July 28, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |