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US Food and Drug Administration Application Approval
- "iWeBB electronic Laboratory Information System (iWeBB-eLIS) v1.0.0, also referred to as eLIS, is software intended for use by trained blood banking laboratory personnel for managing patient information, blood transfusion requirements, blood specimen test orders, laboratory test results, blood product orders (including safety/compatibility checks for attributes, antibodies, and antigens), and patient transfusion histories. eLIS also interfaces to popular blood testing laboratory equipment and provides system reporting, printing, and data exporting features.
- WellSky™ Blood – Emergency Issue 2020 R1 is intended to support the performance of HCLL™ Transfusion by enabling that device to perform according to its intended use by addressing all phases of transfusion services activities, and assist transfusion service personnel they relate to the emergency issue of blood products:
- Allow for emergency patient safety protocols.
- Issue blood products under emergency conditions.
- Confirmation scan of correct transfusion slip on correct unit.
- Use of emergency issue products on a mobile device and desktop workstation.
- Blood Product Administration Module Version 3-2020. The Blood Product Administration Module is a software module intended for use by healthcare professionals to assist in the identification of patients and blood products for transfusion."
Excerpt from the US Food and Drug Administration of Biological Device Application.
List of Biological Device Application Approved by FDA at 2020 Biological Device Application Approvals.
Darnall Medical Library Mobile Resources
For an access to a list of Darnall Medical Library mobile resources, please visit the library guide Mobile Resources.
Biological Device Applications
Darnall Medical Library | Walter Reed NMMC | Building 1, Room 3458 | 8955 Wood Road | Bethesda, MD 20889 | 301-295-1184/85 | Open Monday-Friday, 0700-1730
After-hours access to the library is available to WRNMMC Staff via the CDO at 301-295-4611.