Duns Number:621904622
Device Description: The Emergency Preparedness Medical Kit -Traveler Kit, Bleeding and CPR Basic kit is a high The Emergency Preparedness Medical Kit -Traveler Kit, Bleeding and CPR Basic kit is a high-quality emergency items such as the SWAT-Tourniquet and a CPR face shield to address major life-threatening bleeding and cardiac arrest.
Catalog Number
01423BC
Brand Name
Traveler Kit (EPMK), Bleeding and CPR Basic
Version/Model Number
01423BC
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
9776995e-7bad-4163-9919-c0f08c93a253
Public Version Date
May 29, 2020
Public Version Number
1
DI Record Publish Date
May 21, 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 |