AccessGUDID - DEVICE: MAXSPLIT (00852359007144)

GUDID

Device Identifier (DI) Information

Brand Name: MAXSPLIT
Version or Model: BMS01B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MAXPERT MEDICAL

Primary DI Number: 00852359007144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066886996 *Terms of Use

Device Description: The MAXSPLIT Pill Splitter with Puncher is crafted of quality and durable FDA compliant food grade plastic ensures that medications are contacting high quality, safe plastic and that the splitter is going to last over repeated use. 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 assists in proper pill alignment and the rubber insert holds pill in place while splitting to help ensure an accurate cut.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
15750	Pill crusher/splitter	A hand-held device designed for crushing or splitting in two medication in the form of a tablet for easier ingestion by a patient who cannot swallow the tablet whole. It is designed for convenience to be carried in the user's pocket or handbag (purse) and typically consists of several pieces that can be easily assembled by the user to crush or split the pill (tablet) by screwing the two main body parts against each other. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHY	Pill Crusher/Cutter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b15a71cd-72a7-4850-8f6d-875a37da0e6c
Public Version Date: September 28, 2022
Public Version Number: 3
DI Record Publish Date: October 26, 2020