Picis Weight Based Dose Converter - The Picis Weight Based Dose Converter is designed - PICIS CLINICAL SOLUTIONS, INC.

Duns Number:105505866

Device Description: The Picis Weight Based Dose Converter is designed for use by trained clinicians to calcula 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.

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More Product Details

Catalog Number

-

Brand Name

Picis Weight Based Dose Converter

Version/Model Number

10C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K121542

Product Code Details

Product Code

NDC

Product Code Name

Calculator, Drug Dose

Device Record Status

Public Device Record Key

cab5d7dc-7780-4851-b456-41e0fcad9646

Public Version Date

November 14, 2019

Public Version Number

1

DI Record Publish Date

November 06, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PICIS CLINICAL SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3
U Unclassified 3