AccessGUDID - DEVICE: VYGON (03660812114585)

GUDID

Device Identifier (DI) Information

Brand Name: VYGON
Version or Model: 800.01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00080001
Company Name: VYGON

Primary DI Number: 03660812114585
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 392994778 *Terms of Use

Device Description: Syringe adaptator - Raccord-réducteur seringue/sonde de petit diamètre - Luer-lock

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
KYX	DISPENSER, LIQUID MEDICATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7bb1bce-8360-4156-bd9b-d9411525bd7f
Public Version Date: June 17, 2021
Public Version Number: 1
DI Record Publish Date: June 09, 2021