Duns Number:001180207
Device Description: First Aid Bleeding Control Cabinet - Core Pro: Contains Four Easy Tear-open Bags; each co First Aid Bleeding Control Cabinet - Core Pro: Contains Four Easy Tear-open Bags; each containing: a SWAT-T Tourniquet; Back-up Elastic Tourniquet; Hemostatic Blood-Clotting Gauze Pad, 4" x4"; Sterile Hema-Seal Dressing Wrap; (2) Trauma Pad Dressings, 5"x9"; (2) Pairs Nitrile Exam Gloves; (ne Pair Bandage Shears; Marker; Bleeding Control Product Usage Guidelines
Catalog Number
91145
Brand Name
First Aid Only
Version/Model Number
91145
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"
-
For Single-Use
-
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
OHO
Product Code Name
First Aid Kit Without Drug
Public Device Record Key
d0373cf9-85e4-4c57-830e-90ae4eda1adb
Public Version Date
June 02, 2021
Public Version Number
1
DI Record Publish Date
May 25, 2021
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 | 303 |