Sunquest Atlas - Sunquest Atlas is a solution set comprised of - CliniSys, Inc

Duns Number:052934841

Device Description: Sunquest Atlas is a solution set comprised of four solutions that can be activated individ Sunquest Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform.• Sunquest Physician Portal• Sunquest Advanced EMR Connectivity• Sunquest Patient Service Center (PSC) Portal• Sunquest Multi-Lab Networking

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More Product Details

Catalog Number

-

Brand Name

Sunquest Atlas

Version/Model Number

2022.1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

JQP

Product Code Name

Calculator/Data Processing Module, For Clinical Use

Device Record Status

Public Device Record Key

4de54bd1-19c0-4933-9b35-34739269a6b2

Public Version Date

October 10, 2022

Public Version Number

2

DI Record Publish Date

April 14, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLINISYS, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 27
2 A medical device with a moderate to high risk that requires special controls. 15