Duns Number:800149346
Device Description: Workplace First Aid Kit intended for treating typical minor wounds, scrapes, abrasions, et Workplace First Aid Kit intended for treating typical minor wounds, scrapes, abrasions, etc. Managed First Aid.
Catalog Number
0102072
Brand Name
Redicare
Version/Model Number
Minor Wound 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
LRR
Product Code Name
First Aid Kit With Drug
Public Device Record Key
978caa5e-1110-4bc2-b508-1384a7d5ada5
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 |