Duns Number:621904622
Device Description: This Emergency Preparedness Medical Kit - Home & Vehicle Plus Kit is a comprehensive medic This Emergency Preparedness Medical Kit - Home & Vehicle Plus Kit is a comprehensive medical kit that is the perfect choice for those seeking more than a basic first aid kit and/or when medical attention is not readily available.
Catalog Number
01375RD
Brand Name
Home & Vehicle Plus Kit, (EPMK) Bag, Red
Version/Model Number
01375RD
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)
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
ebef47de-b37d-4752-87e8-e400f1f2d00b
Public Version Date
May 26, 2020
Public Version Number
1
DI Record Publish Date
May 18, 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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |