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.
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
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"
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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
NDC
Product Code Name
Calculator, Drug Dose
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |