FDA UDI
In Commercial Distribution
🇺🇸 United States
MAXSPLIT
DI: 00852359007182
·
Model: BMS02R
·
MAXPERT MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MAXSPLIT
- Primary DI
- 00852359007182
- Version / Model
- BMS02R
- 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
- 70bdd2ea-2f21-4c7a-88b3-f8bbaedd2fae
Device Description
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.
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 | 00852359007182 | GS1 | ||||
| Package | 10852359007189 | GS1 | PKG | 60 | In Commercial Distribution | |
| Package | 20852359007186 | GS1 | CS | 360 | In Commercial Distribution |