AccessGUDID - DEVICE: CONNECTOR, ADAPTER NEEDLE LUER (B066102357NS1)

GUDID

Device Identifier (DI) Information

Brand Name: CONNECTOR, ADAPTER NEEDLE LUER
Version or Model: 102357NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 102357NS
Company Name: NOVOSCI CORP.

Primary DI Number: B066102357NS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 938289980 *Terms of Use

Device Description: A non-sterile device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. 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?
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.	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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: d88cf532-0058-48f8-8a07-c421d16dd337
Public Version Date: July 13, 2023
Public Version Number: 4
DI Record Publish Date: March 07, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B066102357NS7	20000	B066102357NS1	In Commercial Distribution	CASE
B066102357NS6	15000	B066102357NS1	In Commercial Distribution	PARTIAL CASE
B066102357NS5	10000	B066102357NS1	In Commercial Distribution	PARTIAL CASE
B066102357NS4	5000	B066102357NS1	In Commercial Distribution	PARTIAL CASE
B066102357NS3	2500	B066102357NS1	In Commercial Distribution	PARTIAL CASE
B066102357NS2	1000	B066102357NS1	In Commercial Distribution	PARTIAL CASE