Duns Number:002288215
Device Description: Large Platelet Agitator to continuously keep bags of Platelets moving. To be used alone o Large Platelet Agitator to continuously keep bags of Platelets moving. To be used alone or in conjunction with the Boekel Large Platelet Incubator 301550
Catalog Number
-
Brand Name
Boekel Large Platelet Agitator
Version/Model Number
301300
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
KSQ
Product Code Name
Device, Blood Mixing And Blood Weighing
Public Device Record Key
4dce0be2-4f99-4cd2-9e20-f6d85e12ce0e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 31, 2017
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |