Duns Number:002657679
Device Description: TnT Tourniquets preemie size for infants heads in the NICU to be used to bring forth the v TnT Tourniquets preemie size for infants heads in the NICU to be used to bring forth the veins during IV or blood sampling.
Catalog Number
11TH
Brand Name
Tender and Tiny Tourniquets
Version/Model Number
11TH
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
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
GAX
Product Code Name
Tourniquet, Nonpneumatic
Public Device Record Key
4e570b49-b57e-40af-95de-9dca6234bb71
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
August 03, 2020
Package DI Number
10815090012461
Quantity per Package
12
Contains DI Package
00815090012464
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX