PriZm - PriZm® Central Unit - DIVERSATEK HEALTHCARE, INC.

Duns Number:030650113

Device Description: PriZm® Central Unit

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More Product Details

Catalog Number

H20-4000

Brand Name

PriZm

Version/Model Number

H20-4000

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

-

Product Code Details

Product Code

FFX

Product Code Name

System, Gastrointestinal Motility (Electrical)

Device Record Status

Public Device Record Key

679f1f27-c14c-4362-af4a-517c566b7f7e

Public Version Date

August 23, 2021

Public Version Number

1

DI Record Publish Date

August 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIVERSATEK HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 109
2 A medical device with a moderate to high risk that requires special controls. 207