Duns Number:621904622
Device Description: The Emergency Preparedness Medical Kit (EPMK) – Bleeding and CPR Basic Kit offers a combin The Emergency Preparedness Medical Kit (EPMK) – Bleeding and CPR Basic Kit offers a combination of CPR and severe bleeding supplies, which can be used independently or added to a basic first aid kit to enhance its ability to handle true life-threatening emergencies.
Catalog Number
01428RD
Brand Name
Bleeding & CPR Basic Kit (EPMK)
Version/Model Number
01428RD
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
OHO
Product Code Name
First Aid Kit Without Drug
Public Device Record Key
0ea99406-3440-49e9-a594-200ab0505130
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 |