Duns Number:118492643
Device Description: SWAT-TORG SWAT-T Tourniquet, Orange30-212 MARCH Celox Rapid B-CON 3"x2' OTCHVS01 H*VENT V SWAT-TORG SWAT-T Tourniquet, Orange30-212 MARCH Celox Rapid B-CON 3"x2' OTCHVS01 H*VENT Vented Chest Seal, SingleHHMCB01 Mini-Compression Bandage (Sterile) - 4" x 6" abdominal padGLOVES-2.00.101 Synmax, Blue, Industrial Grade, Powered Free, Latex FreeL01-002 2X4WHITE BLANK LABELP88-100 Pouch, 6X12-LE Kit
Catalog Number
HHECTK-01
Brand Name
Easy Carry Trauma Kit
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 02, 9999
Issuing Agency
In HIBCC
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
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
MHW
Product Code Name
Dressing, Compression
Public Device Record Key
95ea93e0-abba-4655-b1ba-1a3a900ebc7e
Public Version Date
June 15, 2022
Public Version Number
1
DI Record Publish Date
June 07, 2022
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |