AccessGUDID - DEVICE: CONNECTOR, 3/8" X 3/8" X 1/2" CLEAR PAY (B0663213340000)

GUDID

Device Identifier (DI) Information

Brand Name: CONNECTOR, 3/8" X 3/8" X 1/2" CLEAR PAY
Version or Model: 321334-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 321334-000
Company Name: NOVOSCI CORP.

Primary DI Number: B0663213340000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 938289980 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K801404	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7c9e57df-71a1-495c-be56-aae5c74c1776
Public Version Date: June 21, 2023
Public Version Number: 3
DI Record Publish Date: October 06, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B0663213340005	40	B0663213340000	In Commercial Distribution	OUTER SHIPPER
B0663213340003	10	B0663213340000	In Commercial Distribution	INNER CARTON
B0663213340007	30	B0663213340000	In Commercial Distribution	PARTIAL CASE
B0663213340006	20	B0663213340000	In Commercial Distribution	PARTIAL CASE