Duns Number:106793995
Device Description: Centrifuge, Hematocrit, 24-Place, 230v, 50Hz, EU Plug (includes: 24-Place Hematocrit Rotor Centrifuge, Hematocrit, 24-Place, 230v, 50Hz, EU Plug (includes: 24-Place Hematocrit Rotor Kit with Lid and Reading Disk Lid)
Catalog Number
-
Brand Name
Globe Scientific
Version/Model Number
GCH-24-UK
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"
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For Single-Use
-
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
GKG
Product Code Name
Centrifuge, Hematocrit
Public Device Record Key
a658dbf6-1684-403c-8239-73ae6e32b501
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
November 26, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |