DEVICE: Boekel Large Platelet Agitator (00863626000225)

Device Identifier (DI) Information

Boekel Large Platelet Agitator
301300
In Commercial Distribution

BOEKEL INDUSTRIES, INC.
00863626000225
GS1

1
002288215 *Terms of Use
Large Platelet Agitator to continuously keep bags of Platelets moving. To be used alone or in conjunction with the Boekel Large Platelet Incubator 301550
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
KSQ Device, Blood Mixing And Blood Weighing
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4dce0be2-4f99-4cd2-9e20-f6d85e12ce0e
March 29, 2018
2
January 31, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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216-989-1143
rrink@boekelsci.com
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