DEVICE: FILTER, GAS/OXYGEN (B0663010010000)

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Device Identifier (DI) Information

FILTER, GAS/OXYGEN
301001-000
301001-000
NOVOSCI CORP.
B0663010010000
HIBCC
1
A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
Yes
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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
Cardiopulmonary bypass system filter, arterial blood line A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KRI Accessory Equipment, Cardiopulmonary Bypass
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Sterilization

Yes
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 Status

In Commercial Distribution
October 06, 2015

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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
B0663010010005 40 B0663010010000 In Commercial Distribution CASE
B0663010010003 10 B0663010010000 In Commercial Distribution INNER CARTON
B0663010010007 30 B0663010010000 In Commercial Distribution PARTIAL CASE
B0663010010006 20 B0663010010000 In Commercial Distribution PARTIAL CASE
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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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Yes
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Customer Contact

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No Customer Contact currently defined
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