AQUIOS B30166

GUDID 15099590225889

AQUIOS CL Flow Cytometer

BECKMAN COULTER IRELAND INC.

Flow cytometry analyser IVD, semi-automated

• Primary Device ID: 15099590225889
• NIH Device Record Key: f287ac93-380e-417b-97ec-ddc4e106673c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUIOS
• Version Model Number: CL
• Catalog Number: B30166
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	15099590225889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141932

FDA Product Code

• OYE: Flow Cytometric Reagents And Accessories.

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: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [AQUIOS ]

• 15099590225889: AQUIOS CL Flow Cytometer
• 15099590225841: AQUIOS Cleaning Agent
• 15099590225827: AQUIOS Sheath Solution
• 15099590225803: AQUIOS Lysing Reagent Kit
• 15099590225773: AQUIOS Sodium Hypochlorite Solution