DEVICE: Boekel Large Platelet Agitator (00863626000225)
Device Identifier (DI) Information
Boekel Large Platelet Agitator
301300
In Commercial Distribution
BOEKEL INDUSTRIES, INC.
301300
In Commercial Distribution
BOEKEL INDUSTRIES, INC.
Large Platelet Agitator to continuously keep bags of Platelets moving. To be used alone or in conjunction with the Boekel Large Platelet Incubator 301550
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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45226 | Platelet agitator |
A mains electricity (AC-powered), electromechanical device typically used by blood bank and transfusion services to provide gentle agitation (e.g., side-to-side motion) required for platelet storage. The device will typically provide several drawers on which to place containers of platelets. It may include an audible alarm that sounds if agitation does not occur during use.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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KSQ | Device, Blood Mixing And Blood Weighing |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4dce0be2-4f99-4cd2-9e20-f6d85e12ce0e
March 29, 2018
2
January 31, 2017
March 29, 2018
2
January 31, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
216-989-1143
rrink@boekelsci.com
rrink@boekelsci.com