Duns Number:303639066
Device Description: SAFETY Blood Collection Set + Luer Adapter 21G x 3/4" tubing length 7 1/2" (19 cm), single SAFETY Blood Collection Set + Luer Adapter 21G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile, not made with natural rubber latex
Catalog Number
450081
Brand Name
Vacuette
Version/Model Number
450081
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K011786,K080235,K121908,K011786,K080235,K121908,K011786,K080235,K121908
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
8e49eeda-96ca-4d08-b4dd-191edbcc0654
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
29120017570237
Quantity per Package
50
Contains DI Package
19120017570230
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |