Codonics Safe Label System®(SLS) 550i Point of Care Station

GUDID 00814905020373

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items - 143C

CODONICS INC.

Parenteral-nutrition management software

• Primary Device ID: 00814905020373
• NIH Device Record Key: 3efed193-2bc0-428e-a073-81334391fdb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Codonics Safe Label System®(SLS) 550i Point of Care Station
• Version Model Number: 550i PCS - 143C
• Company DUNS: 101533727
• Company Name: CODONICS 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: true
• 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

Customer Support Contacts

• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814905020373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101439

FDA Product Code

• BSZ: Gas-Machine, Anesthesia

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: 2017-12-11

On-Brand Devices [Codonics Safe Label System®(SLS) 550i Point of Care Station]

• 00814905020373: Integrated computer based barcode scan & print system automatically to verify drugs & print la
• 00814905020366: Integrated computer based barcode scan & print system automatically to verify drugs & print la