VistaPoint Software User Interface - User interface in the patient's room - Vital Connect, Inc.

Duns Number:944642730

Device Description: User interface in the patient's room

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More Product Details

Catalog Number

6100-03

Brand Name

VistaPoint Software User Interface

Version/Model Number

6100-03

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

K193343

Product Code Details

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Device Record Status

Public Device Record Key

12837249-5718-4c26-a7f1-c2635337e9ca

Public Version Date

November 10, 2020

Public Version Number

1

DI Record Publish Date

November 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VITAL CONNECT, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 21