Drainage Bag DBAG600H

GUDID 20886333001433

Drainage Bag 600ml

ARGON MEDICAL DEVICES, INC.

Bile collection bag

• Primary Device ID: 20886333001433
• NIH Device Record Key: d1d6112d-1717-48a9-821b-b2e31f64fc59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drainage Bag
• Version Model Number: DBAG600H
• Catalog Number: DBAG600H
• 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	00886333001439 [Primary]
GS1	20886333001433 [Package]; Contains: 00886333001439; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980005

FDA Product Code

• EXF: Bag, Bile Collecting

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: 2016-09-09

On-Brand Devices [Drainage Bag]

• 20886333001433: Drainage Bag 600ml
• 20886333001426: Drainage Bag 600ml
• 20886333220971: Drainage Bag Set