AccessGUDID - DEVICE: Vista® (05020583252028)

GUDID

Device Identifier (DI) Information

Brand Name: Vista®
Version or Model: 25202
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TERUMO BCT, INC.

Primary DI Number: 05020583252028
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801679200 *Terms of Use

Device Description: Information System Version 4, Vista Standard Interface and SafeTrace® BBSI Installation Guide

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?
36149	Blood bank information system	A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, and/or distribute administrative and/or clinical data within blood-bank centres. Specific functions typically include management of blood-donor data, autologous and direct blood unit tracking (e.g., using radio-frequency identification (RFID)], and/or cross-match result determination. It consists of dedicated combined hardware (e.g., computers, terminals, network components, blood unit containers) and software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMH	SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK070001	0
BK150228	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
Storage Environment Temperature: between -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c07df9da-482a-440e-bf3f-f48325c1f0f0
Public Version Date: July 24, 2023
Public Version Number: 8
DI Record Publish Date: September 15, 2016