First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit 384115

GUDID 20886333209655

First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit 20GA (3F) x 65 cm

ARGON MEDICAL DEVICES, INC.

Peripherally-inserted central venous catheter

• Primary Device ID: 20886333209655
• NIH Device Record Key: 49ae6ab4-dabc-4803-a48a-019266537145
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit
• Version Model Number: 384115
• Catalog Number: 384115
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333209651 [Primary]
GS1	20886333209655 [Package]; Contains: 00886333209651; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972262

FDA Product Code

• FOZ: Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

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: 2016-09-21

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• 20886333209716: First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit 18GA (4F) x 65cm
• 20886333209655: First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit 20GA (3F) x 65 cm