FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sunquest Application Interfacing
DI: B236AI5300
·
Model: 5.3
·
CliniSys, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Sunquest Application Interfacing
- Primary DI
- B236AI5300
- Version / Model
- 5.3
- Company Name
- CliniSys, Inc
- Labeler DUNS
- 052934841
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-23
- Public Version
- 3
- Public Version Date
- 2023-07-24
- Public Version Status
- Update
- Public Device Record Key
- 66f28d63-3cb0-409e-9b64-50415c42943e
- Distribution End Date
- 2021-10-29
Device Description
Sunquest Application Interface (AI) is to provide interfaces between client systems and Sunquest products to support laboratories in the management of laboratory workflow (order entry through reporting) and transfer test results and information
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 |
|---|---|---|---|---|
| OUG | Medical Device Data System | General Hospital | 880.6310 | 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 | B236AI5300 | HIBCC |