Duns Number:303639066
Device Description: ESR pipette with adapter, graduated 200 mm for 454073
Catalog Number
727111
Brand Name
Vacuette
Version/Model Number
727111
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
JPH
Product Code Name
TEST, ERYTHROCYTE SEDIMENTATION RATE
Public Device Record Key
97124bab-bb97-4ff9-971e-5eb65dcc4fd0
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 25, 2020
Package DI Number
39120017578155
Quantity per Package
4
Contains DI Package
29120017578158
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 |