Cerner CareAware iBus

GUDID 00853023006128

CERNER CORPORATION

Medical equipment clinical data interfacing software

• Primary Device ID: 00853023006128
• NIH Device Record Key: 5406ddc3-0bca-4e2a-9f23-0663e2f9c20b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cerner CareAware iBus
• Version Model Number: CareAwareiBus5
• 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	00853023006128 [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