VENI-GARD 750-4181

GUDID 20653405014642

VeniGard ML

Conmed Corporation

Adhesive bandage Adhesive bandage Adhesive bandage

• Primary Device ID: 20653405014642
• NIH Device Record Key: cba8f76e-779a-468d-a820-f09b15a0f500
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENI-GARD
• Version Model Number: 750-4181
• Catalog Number: 750-4181
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 150
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405014648 [Unit of Use]
GS1	10653405014645 [Primary]
GS1	20653405014642 [Package]; Contains: 10653405014645; Package: Box [150 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935389

FDA Product Code

• KMK: DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-04-28

On-Brand Devices [VENI-GARD]

• 20653405014642: VeniGard ML
• 20653405014611: Veni-Gard TPN
• 20653405014574: Veni-Gard AP
• 20653405014437: 730-4432B Veni-Gard TM Jr. Bulk
• 20653405014420: Veni-Gard TM Jr.
• 20653405014338: Veni-Gard SP Bulk
• 20653405014321: Veni-Gard SP
• 20653405014277: 705-4431B VeniGard TM Bulk
• 20653405014260: VeniGard TM