Duns Number:131084188
Device Description: BLEEDING CONTROL KIT BASIC-VACCUM SEAL
Catalog Number
-
Brand Name
SAM Bleeding Control Kit
Version/Model Number
KT901-V-EN
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
OJS
Product Code Name
Tourniquet Kit
Public Device Record Key
2adecb41-ded2-40ca-a761-0ced8d14f834
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 2022
Package DI Number
10822045000251
Quantity per Package
10
Contains DI Package
00822045000254
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| U | Unclassified | 3 |