Control Syringe 193221

GUDID 20886333207279

12cc Dosage Control Syringe FR/TR/FM

ARGON MEDICAL DEVICES, INC.

General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: 20886333207279
• NIH Device Record Key: b41ce769-4d87-465c-97e8-867939f8757f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control Syringe
• Version Model Number: 193221
• Catalog Number: 193221
• 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	00886333207275 [Primary]
GS1	20886333207279 [Package]; Contains: 00886333207275; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911732

FDA Product Code

• IZI: System, X-Ray, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-12
• Device Publish Date: 2016-09-09

On-Brand Devices [Control Syringe]

• 20886333207330: 12cc Soft Touch Control Syringe FR/TR/RA w/Reservoir
• 20886333207323: 12cc Control Syringe ST/FR/TR/FM w/Reservoir
• 20886333207316: 12cc Soft Touch Control Syringe FG/PP/RA w/Reservoir
• 20886333207286: 12cc Dosage Control Syringe FR/TR/RA
• 20886333207279: 12cc Dosage Control Syringe FR/TR/FM
• 20886333207262: 10cc Dosage Control Syringe – FR/TR/RA
• 20886333207248: 12cc Control Syringe – FG/TR/RA w/Reservoir
• 20886333207231: 12cc Control Syringe – FR/PP/RA w/Reservoir
• 20886333207224: 12cc Control Syringe – FR/PP/FM w/Reservoir
• 20886333207217: 12cc Control Syringe – FR/TR/RA w/Reservoir
• 20886333207200: 12cc Control Syringe FR/TR/FM w/Reservoir
• 20886333207187: 10cc Control Syringe FR/TR/RA w/Reservoir
• 20886333207170: 10cc Control Syringe FR/TR/FM w/Reservoir
• 20886333207163: 10cc Control Syringe FG/PP/FM w/Reservoir