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electronic Laboratory Information System

FDA UDI

Class II (US FDA UDI)

by Carter Bloodcare

Identity

Trade Name
electronic Laboratory Information System FDA UDI
Generic Name
Blood bank information system application software FDA UDI
Device Name
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. FDA UDI
Model / Reference
1.0 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00857222008013 FDA UDI
FDA Product Code
MMH FDA UDI
GMDN Term
Blood bank information system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9165 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Blood bank information system application software

electronic Laboratory Information System by Carter Bloodcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood bank information system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carter Bloodcare

Sources (1)

  • FDA UDI 01ced847-c676-4357-b30a-41c08ab593e4 34 fields · synced May 30, 2026