Intracath 384900

GUDID 20886333210101

Intracath 16ga x 8" I.V. Catheter/Needle Unit w/ Wire Stylet (14ga x 2" Needle)

ARGON MEDICAL DEVICES, INC.

Peripheral vascular catheter

• Primary Device ID: 20886333210101
• NIH Device Record Key: 27ea5a9b-9b3e-444f-bee9-93d170ca5517
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intracath
• Version Model Number: 384900
• Catalog Number: 384900
• 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: 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333210107 [Primary]
GS1	20886333210101 [Package]; Contains: 00886333210107; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K821372

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

On-Brand Devices [Intracath]

• 20886333210163: Intracath 19ga x 24" I.V. Catheter/Needle Unit w/ Wire Stylet (17ga x 2" Needle)
• 20886333210156: Intracath 16ga x 24" I.V. Catheter/Needle Unit w/ Wire Stylet (14ga x 2" Needle)
• 20886333210149: Intracath 19ga x 12" I.V. Catheter/Needle Unit w/ Wire Stylet (17ga x 2" Needle)
• 20886333210132: Intracath 16ga x 12" I.V. Catheter/Needle Unit w/ Wire Stylet (14ga x 2" Needle)
• 20886333210125: Intracath 22ga x 8" I.V. Catheter/Needle Unit w/ Wire Stylet (19ga x 2" Needle)
• 20886333210118: Intracath 19ga x 8" I.V. Catheter/Needle Unit w/ Wire Stylet (17ga x 2" Needle)
• 20886333210101: Intracath 16ga x 8" I.V. Catheter/Needle Unit w/ Wire Stylet (14ga x 2" Needle)