UltraStream Chronic Dialysis Catheter Peel Away Kit 32401528

GUDID 10886333222831

UltraStream Chronic Dialysis Catheter Peel Away Kit 15.5F x 28cm

ARGON MEDICAL DEVICES, INC.

Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 10886333222831
• NIH Device Record Key: fc6b3478-6dea-40e7-8ed8-8fefd520596d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraStream Chronic Dialysis Catheter Peel Away Kit
• Version Model Number: 32401528
• Catalog Number: 32401528
• 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: true
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00886333222834 [Primary]
GS1	10886333222831 [Package]; Contains: 00886333222834; Package: Box [1 Units]; In Commercial Distribution
GS1	20886333222838 [Package]; Contains: 00886333222834; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102043

FDA Product Code

• MSD: Catheter, Hemodialysis, Implanted

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [UltraStream Chronic Dialysis Catheter Peel Away Kit]

• 10886333222862: UltraStream Chronic Dialysis Catheter Peel Away Kit 15.5F x 40cm
• 10886333222855: UltraStream Chronic Dialysis Catheter Peel Away Kit 15.5F x 36cm
• 10886333222848: UltraStream Chronic Dialysis Catheter Peel Away Kit 15.5F x 32cm
• 10886333222831: UltraStream Chronic Dialysis Catheter Peel Away Kit 15.5F x 28cm
• 10886333222824: UltraStream Chronic Dialysis Catheter Peel Away Kit 15.5F x 24cm