DEVICE: CONNECTOR, 3/8" X 1/2" W/OUT PART LINE (B066331034NS1)
Device Identifier (DI) Information
CONNECTOR, 3/8" X 1/2" W/OUT PART LINE
331034NS
In Commercial Distribution
331034NS
NOVOSCI CORP.
331034NS
In Commercial Distribution
331034NS
NOVOSCI CORP.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
64466 | Non-ISO80369-standardized small-bore linear connector, single-use |
A small, non-powered, noninvasive, small-bore, tubular, two-way/linear connector with connections at each end (typically barbed, bayonet, conical, threaded and/or non-Luer-slip) which are not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp, tubing nor puncturing component, and is not a dedicated gas-line connector. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KRI | Accessory Equipment, Cardiopulmonary Bypass |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K802542 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
77f5d684-3534-4e95-abc7-53a4ffe7f4bd
July 14, 2023
3
October 13, 2015
July 14, 2023
3
October 13, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B066331034NS5 | 1000 | B066331034NS1 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
B066331034NS0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-854-0567
info@novosci.com
info@novosci.com