DEVICE: CONN, EQUAL WYE 3/16" (B066C310B1)

Device Identifier (DI) Information

CONN, EQUAL WYE 3/16"
C310B
In Commercial Distribution
C310B
NOVOSCI CORP.
B066C310B1
HIBCC

200
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
KOC Accessories, Blood Circuit, Hemodialysis
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FDA Premarket Submission

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

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 Record Status

1796ee17-3945-4462-91fc-a33de950a615
March 29, 2018
2
September 14, 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
B066C310B5 1000 B066C310B1 In Commercial Distribution CASE
B066C310B4 800 B066C310B1 In Commercial Distribution PARTIAL CASE
B066C310B3 600 B066C310B1 In Commercial Distribution PARTIAL CASE
B066C310B2 400 B066C310B1 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: B066C310B0 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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