FDA UDI
In Commercial Distribution
🇺🇸 United States
Clinisys Atlas
DI: B236CATL202510
·
Model: 2025.1
·
CliniSys, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Clinisys Atlas
- Primary DI
- B236CATL202510
- Version / Model
- 2025.1
- Company Name
- CliniSys, Inc
- Labeler DUNS
- 052934841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-06
- Public Version
- 1
- Public Version Date
- 2026-01-14
- Public Version Status
- New
- Public Device Record Key
- 3bdea4af-f4e5-4c9d-9441-1795c27fe1f3
Device Description
Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform. • Clinisys Physician Portal • Clinisys Advanced EMR Connectivity • Clinisys Patient Service Center (PSC) Portal • Clinisys Multi-Lab Networking
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 |
|---|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | Clinical Chemistry | 862.2100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44082 | Clinical laboratory information system application software | An application software program, routines, and/or algorithms 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 clinical laboratory services and facilities. It is typically supplied for installation into a dedicated information system used in the clinical laboratory 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 | B236CATL202510 | HIBCC |