RNA Medical CVC 123

GUDID 10851290002550

Carton for CVC 123

Rna Medical Division

Flow cytometer calibration/verification solution IVD

• Primary Device ID: 10851290002550
• NIH Device Record Key: ad9dbc8c-1a4e-46f0-99db-cb90138cbc71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RNA Medical
• Version Model Number: CVC 123
• Catalog Number: CVC 123
• Company DUNS: 101187037
• Company Name: Rna Medical Division
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10851290002550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943754

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-19
• Device Publish Date: 2020-08-11

On-Brand Devices [RNA Medical]

• 10851290002550: Carton for CVC 123
• 10851290002567: RNA Medical CVC 223 Multi-Level Carton