Duns Number:604208868
Device Description: #MMSBK-02 Severe Bleeding Kit StandardContents: (1) Swat-T Tourniquet, (1) Celox 2gm, (2) #MMSBK-02 Severe Bleeding Kit StandardContents: (1) Swat-T Tourniquet, (1) Celox 2gm, (2) Gauze Bandage 3", (1) EMS Shears 7.5", (2) Glove L/F Nitrile
Catalog Number
MMSBK-02
Brand Name
Motion Medical Distributing
Version/Model Number
MMSBK-02
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
LRO
Product Code Name
General Surgery Tray
Public Device Record Key
6ada6520-1a11-4cf9-b643-a902be137766
Public Version Date
October 08, 2020
Public Version Number
3
DI Record Publish Date
November 01, 2016
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 190 |