Cerner CareAware iBus

GUDID 00853023006012

CERNER CORPORATION

Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software

• Primary Device ID: 00853023006012
• NIH Device Record Key: 38be81ea-3b81-4af7-9368-8c9ed4c7c855
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cerner CareAware iBus
• Version Model Number: CareAwareiBus6
• Company DUNS: 042410688
• Company Name: CERNER CORPORATION
• 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: false
• Manufacturing Date: false
• 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	00853023006012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093134

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

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: 2018-11-08
• Device Publish Date: 2016-09-24

On-Brand Devices [Cerner CareAware iBus]

• 00853023006128: CareAwareiBus5
• 00853023006012: CareAwareiBus6