Duns Number:303639066
Device Description: VACUETTE® SAFELINK Holder with male luer lock single-packed, not made with natural rubber VACUETTE® SAFELINK Holder with male luer lock single-packed, not made with natural rubber latex
Catalog Number
450210
Brand Name
Vacuette
Version/Model Number
450210
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
K180545,K180545,K180545
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
3a2e2c60-bb1b-44a0-b7cc-d7d91aa05327
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
November 14, 2018
Package DI Number
39120049207481
Quantity per Package
8
Contains DI Package
29120049207484
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 |