Duns Number:066886996
Device Description: Safety is not only delivered with the integrated blade guard to prevent accidental blade c Safety is not only delivered with the integrated blade guard to prevent accidental blade contact, but also with the premium FDA compliant food grade materials that MAXSPLIT™ is produced; latex-free, transparent plastic. You can feel safe that MAXSPLIT will protect you from blade contact and confident to know that your medications are in contact only with high quality, safe plastic.When opening MAXSPLIT™, you will find an ergonomic U-shaped holder that allows pills of various sizes, shapes and thicknesses to be easily positioned and split safely and accurately. This U-shaped opening with alignment line assists in proper pill alignment and the rubber insert holds the pill in place while splitting to help ensure an accurate cut.
Catalog Number
-
Brand Name
MAXSPLIT
Version/Model Number
BMS02B
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"
-
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
-
Product Code
OHY
Product Code Name
Pill Crusher/Cutter
Public Device Record Key
38aaf00b-76ef-4bbf-b787-18b3ab33ad10
Public Version Date
September 28, 2022
Public Version Number
3
DI Record Publish Date
October 26, 2020
Package DI Number
10852359007172
Quantity per Package
60
Contains DI Package
00852359007175
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PKG
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |