Duns Number:303639066
Device Description: VACUETTE® TUBE 1.5 ml 4NC ESR sodium citrate 3.2% 9x120 black cap, PP
Catalog Number
729073
Brand Name
Vacuette
Version/Model Number
729073
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 14, 2021
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
GHC
Product Code Name
TUBE, SEDIMENTATION RATE
Public Device Record Key
f3542cc4-6efb-4a0e-9de3-45873c68e512
Public Version Date
April 16, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
39120017575260
Quantity per Package
16
Contains DI Package
29120017575263
Package Discontinue Date
April 14, 2021
Package Status
Not 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 |