AccessGUDID - DEVICE: CONNECTOR, STRAIGHT 3/8" X 3/8" W/LUER (B066C135B1)

GUDID

Device Identifier (DI) Information

Brand Name: CONNECTOR, STRAIGHT 3/8" X 3/8" W/LUER
Version or Model: C135B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C135B
Company Name: NOVOSCI CORP.

Primary DI Number: B066C135B1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 938289980 *Terms of Use

Device Description: A 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?
64467	Luer/non-ISO80369-standardized linear connector, single-use	A small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, bayonet, collet, conical, threaded or non-Luer-slip) 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 incorporate a filter, valve, clamp, tubing or an external puncturing component. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOC	Accessories, Blood Circuit, Hemodialysis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K821495	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

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: 5b8db40b-efad-481c-8895-0c0212b5062e
Public Version Date: July 11, 2023
Public Version Number: 4
DI Record Publish Date: September 14, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B066C135B5	1000	B066C135B1	In Commercial Distribution	CASE
B066C135B4	800	B066C135B1	In Commercial Distribution	PARTIAL CASE
B066C135B3	600	B066C135B1	In Commercial Distribution	PARTIAL CASE
B066C135B2	400	B066C135B1	In Commercial Distribution	PARTIAL CASE