Duns Number:303639066
Device Description: VACUETTE® EVOPROTECT SAFETY Blood Collection/Infusion Set 21G x 3/4" tubing length 7 1/2" VACUETTE® EVOPROTECT SAFETY Blood Collection/Infusion Set 21G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile, not made with natural rubber latex or DEHP
Catalog Number
450120
Brand Name
VACUETTE
Version/Model Number
450120
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
K173757,K173757,K173757
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
17bf3f66-9098-4185-8815-3708621f39ac
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
March 03, 2020
Package DI Number
39120049206583
Quantity per Package
18
Contains DI Package
29120049206586
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 |