DEVICE: electronic Laboratory Information System (00857222008013)

Device Identifier (DI) Information

electronic Laboratory Information System
1.0
In Commercial Distribution

CARTER BLOODCARE
00857222008013
GS1

1
073169765 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
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FDA Product Code

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Product Code Product Code Name
MMH Blood Establishment Computer Software And Accessories
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK200491 0
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Sterilization

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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Size Type Text
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Device Record Status

01ced847-c676-4357-b30a-41c08ab593e4
December 18, 2020
1
December 10, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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