Duns Number:621904622
Device Description: The EPMK - Mobile Aid Kit (MAK) offers an extremely robust and comprehensive medical kit e The EPMK - Mobile Aid Kit (MAK) offers an extremely robust and comprehensive medical kit equipped to handle medical and trauma emergencies ranging from everyday cuts and headaches to more serious life-threatening injuries such as arterial bleeding.
Catalog Number
01376HC
Brand Name
Mobile Aid Kit (MAK), Yellow, Hard Case
Version/Model Number
01376HC
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
06234a2d-debf-42ce-9321-32e3929b1fe3
Public Version Date
May 27, 2020
Public Version Number
1
DI Record Publish Date
May 19, 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 |