AccessGUDID - DEVICE: ABO QuickPass V 1.0.0 (00860009119444)

GUDID

Device Identifier (DI) Information

Brand Name: ABO QuickPass V 1.0.0
Version or Model: 1.0.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Blood Bank Computer System

Primary DI Number: 00860009119444
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 074621140 *Terms of Use

Device Description: ABO QuickPass is a software application intended to allow donors to complete Computer Assisted Self Interviews (CASI) and computer assisted blood donor registrations. ABO QuickPass works in tandem with compatible blood bank systems to identify repeat donors, retrieve the donor’s donation eligibility, and retrieve the donor history questionnaire appropriate for the donor and intended donation. Upon completion of ABO QuickPass all information which is entered by the donor is transferred to compatible blood bank systems. CASIs can be completed using the Internet via the ABO QuickPass web portal or at the donor site via the ABO QuickPass kiosk. CASIs which are completed via the web portal produce an encrypted barcode, which can be decrypted and imported on the day of donation into the ABO QuickPass kiosk for transfer of question responses to the facilities compatible blood bank system

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMH	Blood Establishment Computer Software And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK140198	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: 2b02be66-2fb8-45c9-8170-e6df48a988fd
Public Version Date: May 06, 2025
Public Version Number: 1
DI Record Publish Date: April 28, 2025