FDA UDI
In Commercial Distribution
🇺🇸 United States
MAXSPLIT
DI: 00852359007144
·
Model: BMS01B
·
MAXPERT MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MAXSPLIT
- Primary DI
- 00852359007144
- Version / Model
- BMS01B
- Company Name
- MAXPERT MEDICAL
- Labeler DUNS
- 066886996
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-26
- Public Version
- 3
- Public Version Date
- 2022-09-28
- Public Version Status
- Update
- Public Device Record Key
- b15a71cd-72a7-4850-8f6d-875a37da0e6c
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHY | Pill Crusher/Cutter | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852359007144 | GS1 | ||||
| Package | 10852359007141 | GS1 | PKG | 60 | In Commercial Distribution | |
| Package | 20852359007148 | GS1 | CS | 360 | In Commercial Distribution |