Navios EX B91238

GUDID 15099590683252

NAVIOS EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7

BECKMAN COULTER IRELAND INC.

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD

• Primary Device ID: 15099590683252
• NIH Device Record Key: e24fd550-bc5e-427f-bfee-89ca1b11bd7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navios EX
• Version Model Number: OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7
• Catalog Number: B91238
• 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	15099590683252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162897

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: 2017-07-06

On-Brand Devices [Navios EX]

• 15099590683276: NAVIOS EX TETRA SOFTWARE V2.0 NEW USER
• 15099590683269: NAVIOS EX OFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7
• 15099590683252: NAVIOS EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7
• 15099590683245: NAVIOS EX ACQUISITION NEW USER SOFTWARE V2.0 WIN 7
• 15099590683009: NAVIOS EX FLOW CYTOMETER (6 COLOR/2 LASER)
• 15099590682996: NAVIOS EX FLOW CYTOMETER (8 COLOR/2 LASER)
• 15099590677466: Navios EX Flow Cytometer (10 Color/3 Laser)