WellSky Transfusion
Basic Information
- Brand Name
- WellSky Transfusion
- Primary DI
- B105TRANSFUSION2020
- Version / Model
- 2020
- Company Name
- WELLSKY CORPORATION
- Labeler DUNS
- 177240249
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-09
- Public Version
- 1
- Public Version Date
- 2021-02-17
- Public Version Status
- New
- Public Device Record Key
- e52b6ca0-22f9-4aea-b070-614ffa89c121
Device Description
WellSky Tranfusion 2020 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2020 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT 128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bi-directional) WellSky Transfusion 2020 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
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
- Yes
- 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 | B105TRANSFUSION2020 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK160066 | 0 |