DEVICE: CONN, Y 3/8" X 3/8" X 1/2" W/LUER (B0663423340000)

Device Identifier (DI) Information

CONN, Y 3/8" X 3/8" X 1/2" W/LUER
342334-000
In Commercial Distribution
342334-000
NOVOSCI CORP.
B0663423340000
HIBCC

1
938289980 *Terms of Use
A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
Cardiopulmonary bypass system tubing connector A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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 Record Status

919dcd58-5439-4641-b7ac-febd59cc337d
March 29, 2018
2
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
B0663423340005 100 B0663423340000 In Commercial Distribution OUTER SHIPPER
B0663423340003 25 B0663423340000 In Commercial Distribution INNER CARTON
B0663423340007 75 B0663423340000 In Commercial Distribution PARTIAL CASE
B0663423340006 50 B0663423340000 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
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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