Duns Number:106793995
Device Description: ESR: EZ-Rate Westergren Pipette, 200 Tests (For use with 13mm Blood Collection Tube)
Catalog Number
-
Brand Name
Globe Scientific
Version/Model Number
3480
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)
-
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
987b4b22-7b76-4bfc-be60-dae21ad26d7d
Public Version Date
December 04, 2019
Public Version Number
1
DI Record Publish Date
November 26, 2019
Package DI Number
00840095606035
Quantity per Package
10
Contains DI Package
00840095606028
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 184 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |