DEVICE: CONNECTOR, Y 3/8" X 1/2" X 1/2" W/LUER (B066342344NS1)
Device Identifier (DI) Information
CONNECTOR, Y 3/8" X 1/2" X 1/2" W/LUER
342344NS
In Commercial Distribution
342344NS
NOVOSCI CORP.
342344NS
In Commercial Distribution
342344NS
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? |
---|---|---|---|---|
64696 | Non-ISO80369-standardized small-bore multichannel connector, single-use |
A small, non-powered, noninvasive, small-bore tubular connector with three or more connections (typically barbed, bayonet, conical, threaded and/or non-Luer-slip), none of which are designed according to ISO 80369 (standard for small-bore connectors for liquids and gases), intended to connect three or more luminal devices (e.g., tubing, container) with each other during a medical procedure. It is typically T-, Y- or cross-shaped; it does not incorporate a filter, valve, clamp, tubing or puncturing component, and is not a dedicated gas-line connector. This is a single-use device.
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Active | false |
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 |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e2dcca2e-f6fc-4e56-8f74-3b32183c4b32
July 14, 2023
4
October 13, 2015
July 14, 2023
4
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 |
---|---|---|---|---|---|
B066342344NS5 | 1000 | B066342344NS1 | 2021-12-14 | Not in Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
B066342344NS0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-854-0567
info@novosci.com
info@novosci.com