DEVICE: Bowman Perfusion Monitor, 120V (B238H000007100)

Device Identifier (DI) Information

Bowman Perfusion Monitor, 120V
Model 500
In Commercial Distribution
H0000-0710
HEMEDEX, INC
B238H000007100
HIBCC

1
128045676 *Terms of Use
Perfusion Monitor, 120V
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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
Patient monitoring system module, intracranial pressure A small unit dedicated to the detection, measurement, and recording of intracranial pressure (ICP). It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the parameter/information measured and provided by this module.
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FDA Product Code

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Product Code Product Code Name
DPW Flowmeter, Blood, Cardiovascular
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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

7999c3dc-8031-41af-90cb-f52a493247b3
March 29, 2018
2
September 21, 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
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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