DoVac Elite - The DoVac Elite system is a web-based application - IT SYNERGISTICS, LLC

Duns Number:013847849

Device Description: The DoVac Elite system is a web-based application that provides functions for managing don The DoVac Elite system is a web-based application that provides functions for managing donors, donations and the collection process. The system identifies results and responses throughout the process that can be considered ‘high-risk’ to the general blood supply which notifies and allows a staff member to complete a review to determine donor suitability. The DoVac Elite application is capable of capturing all information in the collection process: registration, physical exam, computer assisted medical questionnaire, donor consent, donation identification number assignment, phlebotomy, supervisor review and audit. The system maintains a complete record of all interactions throughout including the donation process, device interfaces, auditing and donor/donation maintenance functions.

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More Product Details

Catalog Number

-

Brand Name

DoVac Elite

Version/Model Number

2.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

BK140091

Product Code Details

Product Code

MMH

Product Code Name

Blood Establishment Computer Software And Accessories

Device Record Status

Public Device Record Key

96ec54a9-9e96-43ec-9cbc-36e4dfbaed20

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IT SYNERGISTICS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2