Duns Number:537396330
Device Description: CRYOFUGE 5500i 120V 60HZ HERAEUS
Catalog Number
75004475
Brand Name
Thermo Scientific
Version/Model Number
heraeus Cryofuge 5500i
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
-
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
KSO
Product Code Name
Centrifuge, Blood-Bank For In Vitro Diagnostic Use
Public Device Record Key
c18aca2c-8ed4-461a-ace9-319b99393fb6
Public Version Date
October 22, 2018
Public Version Number
1
DI Record Publish Date
September 21, 2018
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 | 156 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |