Skater™ Safety Centesis Catheter 700608016

GUDID 20886333225549

Skater™ Safety Centesis Catheter 8F x 16cm with Pigtail and Blunt Retracting Stylet

ARGON MEDICAL DEVICES, INC.

Abdominal paracentesis needle, single-use

• Primary Device ID: 20886333225549
• NIH Device Record Key: 0421ad23-a521-4934-b18f-1ffd99f772bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Skater™ Safety Centesis Catheter
• Version Model Number: 700608016
• Catalog Number: 700608016
• Company DUNS: 140727624
• Company Name: ARGON MEDICAL DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00886333225545 [Primary]
GS1	20886333225549 [Package]; Contains: 00886333225545; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• OJT: Aspiration Tray

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: 2022-07-28
• Device Publish Date: 2022-07-20

On-Brand Devices [Skater™ Safety Centesis Catheter]

• 20886333225549: Skater™ Safety Centesis Catheter 8F x 16cm with Pigtail and Blunt Retracting Stylet
• 20886333225532: Skater™ Safety Centesis Catheter 6F x 16cm with Pigtail and Blunt Retracting Stylet
• 20886333225044: Skater™ Safety Centesis Catheter 8F x 12cm with Air Lock Valve
• 20886333225037: Skater™ Safety Centesis Catheter 5F x 10cm with Air Lock Valve