Duns Number:303639066
Device Description: VACUETTE® SECONDARY Tube MULTIPLEX PET 13x75 mm without cap, PREMIUM
Catalog Number
459011
Brand Name
Vacuette
Version/Model Number
459011
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
NNI
Product Code Name
CONTAINER, SPECIMEN, NON-STERILE
Public Device Record Key
083cf34c-fd17-4442-a29b-83e81b04d343
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
39120049200994
Quantity per Package
4
Contains DI Package
29120049200997
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 |