AccessGUDID - DEVICE: Ortho Connect (05060496770066)

GUDID

Device Identifier (DI) Information

Brand Name: Ortho Connect
Version or Model: 3.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMEDICAL DATA SOLUTIONS LIMITED

Primary DI Number: 05060496770066
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 502054265 *Terms of Use

Device Description: ORTHO CONNECT™ Software is designed to collect data from the Ortho Clinical Diagnostics blood typing instruments and its proprietary immunohematology reagent system, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results from testing, assigns outcomes to individual samples according to configured rules, and formats output files that can be sent to a Laboratory Information Management System (LIMS). ORTHO CONNECT™ Software is intended to be used by Blood Establishments and by personnel who are trained in its operation.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43472	Laboratory instrument/analyser application software IVD	An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSZ	System, Test, Automated Blood Grouping And Antibody

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK190434	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 92d8c6f7-696d-4952-89b2-c5307394b619
Public Version Date: March 20, 2025
Public Version Number: 3
DI Record Publish Date: November 18, 2020