FDA UDI
In Commercial Distribution
🇺🇸 United States
Clinisys CoPathPlus
DI: B236CPP8030
·
Model: 8.0.3
·
CliniSys, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Clinisys CoPathPlus
- Primary DI
- B236CPP8030
- Version / Model
- 8.0.3
- Company Name
- CliniSys, Inc
- Labeler DUNS
- 052934841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-18
- Public Version
- 1
- Public Version Date
- 2026-02-26
- Public Version Status
- New
- Public Device Record Key
- 7dda158f-2e36-4223-9640-c9e66949d27a
Device Description
The intended use of Clinisys CoPathPlus is to support anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information. This product is intended for use by trained health care and laboratory professionals.
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
- Yes
- 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 |
|---|---|---|---|---|
| NVV | Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System | Clinical Chemistry | 862.2100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44103 | Pathology information system application software | An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of pathology services and facilities. It is typically supplied for installation into a dedicated pathology information system or existing mainframe or decentralized computers/networks. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B236CPP8030 | HIBCC |