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Picis Weight Based Dose Converter

FDA UDI

Class II (US FDA UDI)

by Picis Clinical Solutions, Inc.

Identity

Trade Name
Picis Weight Based Dose Converter FDA UDI
Generic Name
Patient health record information system application software FDA UDI
Device Name
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. FDA UDI
Model / Reference
8.6 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00851831007016 FDA UDI
510(k) Number
K121542 FDA UDI
FDA Product Code
NDC FDA UDI
GMDN Term
Patient health record information system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Patient health record information system application software

Picis Weight Based Dose Converter by Picis Clinical Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient health record information system application software.

Cleared under the same submission

K121542 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Picis Clinical Solutions, Inc.

Sources (1)

  • FDA UDI 0a627b0b-c571-4649-9332-d60f02f4a464 34 fields · synced Jun 8, 2026