DEVICE: Boekel Plasma Thawer (00863626000201)
Device Identifier (DI) Information
Boekel Plasma Thawer
301000
In Commercial Distribution
BOEKEL INDUSTRIES, INC.
301000
In Commercial Distribution
BOEKEL INDUSTRIES, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
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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43434 | Cryopreserved blood/tissue thawing unit |
An electrically-powered device intended to be used to thaw, in a controlled manner, frozen units of whole blood, blood components (e.g., blood cells, plasma), and/or other biological tissues contained in storage cryobags. The device is typically programmable and can use a number of heating methods to achieve thawing (e.g., dry heat, microwave oven, water bath); it may provide agitation and be able to detect when thawing has been completed.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KZL | Device, Warming. Blood And Plasma |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
BK100051 | 0 |
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
50bee903-a03b-4ef9-b5b8-1c63d2ee114a
October 21, 2020
4
September 01, 2016
October 21, 2020
4
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
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
[?]
267-989-1143
rrink@boekelsci.com
rrink@boekelsci.com