Picis Weight Based Dose Converter

GUDID 00851831007016

The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient’s dose for a given agent based on a weight based determination by the clinician. Drug dosing for a patient must be made only after careful consideration of the full clinical status of the patient by the ordering clinician and the software provides no validation as to the appropriateness of the entered weight based dose.

PICIS CLINICAL SOLUTIONS, INC.

Patient health record information system application software

• Primary Device ID: 00851831007016
• NIH Device Record Key: 0a627b0b-c571-4649-9332-d60f02f4a464
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Picis Weight Based Dose Converter
• Version Model Number: 8.6
• Company DUNS: 105505866
• Company Name: PICIS CLINICAL SOLUTIONS, 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: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00851831007016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121542

FDA Product Code

• NDC: Calculator, Drug Dose

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: 2017-04-14

On-Brand Devices [Picis Weight Based Dose Converter]

• 00851831007016: The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any
• 00851831007061: The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any
• 00851831007085: Picis Weight Based Dose Converter: The Picis Weight Based Dose Converter is designed for use by