IRISpec 800-7702

GUDID 10837461002680

IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS

BECKMAN COULTER IRELAND INC.

Multiple urine analyte IVD, control

• Primary Device ID: 10837461002680
• NIH Device Record Key: 421b7ef5-844f-4ab7-a747-ef6caa42d2e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRISpec
• Version Model Number: CA/CB/CC URINE CHEMSITRY CONTROLS
• Catalog Number: 800-7702
• Company DUNS: 985071975
• Company Name: BECKMAN COULTER IRELAND 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: 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	10837461002680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072640

FDA Product Code

• JJW: Urinalysis Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-10-13
• Device Publish Date: 2016-09-07

On-Brand Devices [IRISpec]

• 10837461002680: IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS
• 10837461002611: IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS