Iris® 800-3203

GUDID 10837461002260

Iris® System Cleanser Pack (NA/INTL)

BECKMAN COULTER IRELAND INC.

Wash/cleaning solution IVD, automated/semi-automated system

• Primary Device ID: 10837461002260
• NIH Device Record Key: b4fadaff-a4ec-4f1b-b3cb-ba84f64b1200
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Iris®
• Version Model Number: System Cleanser (NA/INTL)
• Catalog Number: 800-3203
• Company DUNS: 985071975
• Company Name: BECKMAN COULTER IRELAND 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10837461002260 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-10-13
• Device Publish Date: 2016-09-07

On-Brand Devices [Iris®]

• 10837461002260: Iris® System Cleanser Pack (NA/INTL)
• 10837461002239: Iris® Diluent Pack (NA)