AccessGUDID - DEVICE: VENI-GARD (10653405014577)

GUDID

Device Identifier (DI) Information

Brand Name: VENI-GARD
Version or Model: 740-1440
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 740-1440
Company Name: Conmed Corporation

Primary DI Number: 10653405014577
Issuing Agency: GS1
Commercial Distribution End Date: July 19, 2023
Device Count: 500
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: VENI-GARD AP, I.V. Catheter Dressing

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?
61345	Vascular catheterization support/maintenance kit, non-medicated	A collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MGP	Dressing, wound and burn, occlusive

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e7f3639-baf5-45e7-8ca5-05e0191f8743
Public Version Date: August 21, 2024
Public Version Number: 3
DI Record Publish Date: April 28, 2020