Duns Number:001292192
Device Description: TOURNIQUET STRETCH LATEX FREE
Catalog Number
367203
Brand Name
BD Vacutainer® Stretch Latex Free Tourniquet
Version/Model Number
367203
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)
Yes
Over the Counter (OTC)
-
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
0a92933f-d4d6-45b3-906b-1abff247ba7a
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
November 03, 2020
Package DI Number
30382903672036
Quantity per Package
25
Contains DI Package
50382903672030
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfpack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 611 |
2 | A medical device with a moderate to high risk that requires special controls. | 614 |
3 | A medical device with high risk that requires premarket approval | 36 |
U | Unclassified | 4 |