FDA UDI
In Commercial Distribution
🇺🇸 United States
Sanguin Aurora
DI: 05060496770035
·
Model: 2.0
·
BIOMEDICAL DATA SOLUTIONS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sanguin Aurora
- Primary DI
- 05060496770035
- Version / Model
- 2.0
- Company Name
- BIOMEDICAL DATA SOLUTIONS LIMITED
- Labeler DUNS
- 502054265
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-23
- Public Version
- 2
- Public Version Date
- 2020-11-16
- Public Version Status
- Update
- Public Device Record Key
- 9afb7a9f-2204-4e3e-ac93-d663ebfb5d30
Device Description
Sanguin Aurora 2.0 is indicated for use in Clinical Diagnostic Laboratories, Blood Bank and Blood Establishments where it captures test and result data from laboratory equipment. It can be applied to single tests or a panel of tests that are used to screen blood donation (whole blood or plasma) as a pre-requisite to transfusion. Typically these tests would include markers such as Hepatitis Markers and HIV and may include non-viral testing such as ABO and Rhesus confirmation of donors, patient typing and antibody screening.
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
- No
- 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 |
|---|---|---|---|---|
| MMH | Blood Establishment Computer Software And Accessories | Hematology | 864.9165 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44100 | Blood bank 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 administrative and clinical data within blood-bank centres. It accumulates data on blood-donor status and may include algorithms to process blood-bank information. It may perform additional tasks such as autologous and direct unit tracking, cross-match result determination, and/or management of bar-code information and patient history reports. It is typically supplied for installation into a blood bank information system, or mainframe or decentralized computers/networks. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060496770035 | GS1 |