AccessGUDID - DEVICE: Blood Product Questionnaire Module (00860010651209)

GUDID

Device Identifier (DI) Information

Brand Name: Blood Product Questionnaire Module
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BUOY SOFTWARE, LLC

Primary DI Number: 00860010651209
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117546934 *Terms of Use

Device Description: The Blood Product Questionnaire Module supports single and/or multi-site blood establishment collection facilities’ creation of a donor history questionnaire, the collection of donor history by donors, the determination of visit requirements, and the determination of donor eligibility through system logic or via analysis by trained facility staff members

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 [?]
BK231004	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: 718324f9-9dae-4226-b345-002f7744323e
Public Version Date: August 01, 2024
Public Version Number: 1
DI Record Publish Date: July 24, 2024