Axcess Percutaneous Catheter Introducer Kit 496036

GUDID 10886333213389

6F Axcess Percutaneous Catheter Introducer Kit

ARGON MEDICAL DEVICES, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10886333213389
• NIH Device Record Key: 2e398e6e-52f6-4133-8a7b-1ad50ca5333f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axcess Percutaneous Catheter Introducer Kit
• Version Model Number: 496036
• Catalog Number: 496036
• Company DUNS: 140727624
• Company Name: ARGON MEDICAL DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333213382 [Primary]
GS1	10886333213389 [Package]; Contains: 00886333213382; Package: Box [10 Units]; In Commercial Distribution
GS1	20886333213386 [Package]; Contains: 00886333213382; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780126

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-09-09

On-Brand Devices [Axcess Percutaneous Catheter Introducer Kit]

• 10886333213426: 9F Axcess Percutaneous Catheter Introducer Kit
• 10886333213402: 8F Axcess Percutaneous Catheter Introducer Kit
• 10886333213396: 7F Axcess Percutaneous Catheter Introducer Kit
• 10886333213389: 6F Axcess Percutaneous Catheter Introducer Kit
• 10886333213365: 8F Axcess Percutaneous Catheter Introducer Kit
• 10886333213358: 7F Axcess Percutaneous Catheter Introducer Kit
• 10886333213341: 6F Axcess Percutaneous Catheter Introducer Kit
• 10886333213334: 5F Axcess Percutaneous Catheter Introducer Kit
• 10886333213327: 6F Axcess Percutaneous Catheter Introducer Kit
• 10886333213303: 9F Axcess Percutaneous Catheter Introducer Kit
• 10886333213297: 8F Axcess Percutaneous Catheter Introducer Kit
• 10886333213273: 6F Axcess Percutaneous Catheter Introducer Kit
• 10886333213266: 5F Axcess Percutaneous Catheter Introducer Kit
• 10886333213259: 4F Axcess Percutaneous Catheter Introducer Kit