DEVICE: Boekel Large Platelet Incubator (00863626000249)

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Device Identifier (DI) Information

Boekel Large Platelet Incubator
301650

BOEKEL INDUSTRIES, INC.
00863626000249
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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No
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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 storage incubator A mains electricity (AC-powered) device intended to be used by blood bank and transfusion services to store and maintain platelet concentrates within preselected temperature ranges (typically 20º to 24º Celsius). It is a cabinet-like chamber with shelves, and typically includes built-in temperature displays and an alarm triggered by out-of-range temperature variations; some types may in addition have built-in platelet agitators.
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FDA Product Code

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Product Code Product Code Name
KSH Chamber, Environmental For The Storage Of Platelet Concentrate
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Sterilization

No
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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 Status

In Commercial Distribution
September 01, 2016

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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
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No CLOSE

Customer Contact

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267-989-1143
rrink@boekelsci.com
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