electronic Laboratory Information System

GUDID 00857222008013

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.

CARTER BLOODCARE

Blood bank information system application software

• Primary Device ID: 00857222008013
• NIH Device Record Key: 01ced847-c676-4357-b30a-41c08ab593e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: electronic Laboratory Information System
• Version Model Number: 1.0
• Company DUNS: 073169765
• Company Name: CARTER BLOODCARE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857222008013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK200491

FDA Product Code

• MMH: Blood Establishment Computer Software And Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-18
• Device Publish Date: 2020-12-10

Devices Manufactured by CARTER BLOODCARE

• 00857222008037 - Blood Bank Information Management System: 2024-09-17 BBIMS is Blood Establishment Computer Software. It is designed for use in a blood center to support the entry and eligibility p
• 00857222008013 - electronic Laboratory Information System: 2020-12-18iWeBB 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.
• 00857222008013 - electronic Laboratory Information System: 2020-12-18 iWeBB electronic Laboratory Information System (iWeBB- eLIS), also referred to as eLIS, is software for managing patient transfu
• 00857222008006 - Blood Bank Information Management System: 2018-12-31 BBIMS is Blood Establishment Computer Software. It is designed for use in a blood center to support the entry and eligibility p