electronic Laboratory Information System
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Basic Information
- Brand Name
- electronic Laboratory Information System
- Primary DI
- 00857222008013
- Version / Model
- 1.0
- Company Name
- CARTER BLOODCARE
- Labeler DUNS
- 073169765
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-10
- Public Version
- 1
- Public Version Date
- 2020-12-18
- Public Version Status
- New
- Public Device Record Key
- 01ced847-c676-4357-b30a-41c08ab593e4
Device Description
iWeBB electronic Laboratory Information System (iWeBB- eLIS), also referred to as eLIS, is software for managing patient transfusion requirements, patients’ blood specimen tests, and patient laboratory results. eLIS provides the blood bank laboratory with: * Patient management * Request order management * Patient testing management * Product order and fulfillment management including an interface to the blood center’s product inventory * Computer crossmatch and manual crossmatch data management * Interfaces to laboratory instruments. Trained laboratory personnel use eLIS to record patient information, manage specimens, enter single and batch test orders, and maintain test results. In concert with inventory control modules in other blood establishment computer software, eLIS can be used to complete cross match of a patient’s requirements with products in inventory, manage blood orders and maintain product data related to patient transfusions.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 | 00857222008013 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK200491 | 0 |