DEVICE: CAP, NON VENTED FEMALE: BLUE NON-STERILE (B066000325011NS1)

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Device Identifier (DI) Information

CAP, NON VENTED FEMALE: BLUE NON-STERILE
000325-011NS
000325-011NS
NOVOSCI CORP.
B066000325011NS1
HIBCC
5000
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
No
No
Yes
No
No
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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
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
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
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Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
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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 13, 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
B066000325011NS6 30000 B066000325011NS1 In Commercial Distribution CASE
B066000325011NS5 25000 B066000325011NS1 In Commercial Distribution PARTIAL CASE
B066000325011NS4 20000 B066000325011NS1 In Commercial Distribution PARTIAL CASE
B066000325011NS3 15000 B066000325011NS1 In Commercial Distribution PARTIAL CASE
B066000325011NS2 10000 B066000325011NS1 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: B066000325011NS0 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
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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