Centesis Procedure Kit ATPK1001

GUDID 20886333220995

Centesis Procedure Kit 8F x 12cm Skater™ Safety Centesis Catheter with Air Lock Valve

ARGON MEDICAL DEVICES, INC.

Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use Aspiration tray, single-use

• Primary Device ID: 20886333220995
• NIH Device Record Key: 038991c4-a13e-4ef1-baa4-98464b84be19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Centesis Procedure Kit
• Version Model Number: ATPK1001
• Catalog Number: ATPK1001
• 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: 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
• 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
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• 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	00886333220991 [Primary]
GS1	20886333220995 [Package]; Contains: 00886333220991; 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 [Centesis Procedure Kit]

• 20886333220902: Centesis Procedure Kit 8F x 16cm Skater™ Safety Centesis Catheter with Pigtail and Blunt Retra
• 20886333220889: Centesis Procedure Kit 6F x 16cm Skater™ Safety Centesis Catheter with Pigtail and Blunt Retra
• 20886333221008: Centesis Procedure Kit 5F x 10cm Skater™ Safety Centesis Catheter with Air Lock Valve
• 20886333220995: Centesis Procedure Kit 8F x 12cm Skater™ Safety Centesis Catheter with Air Lock Valve
• 20886333220735: Centesis Procedure Kit Drug Free with Safety Devices and Thoracentesis Catheter with 14ga Needle