Zvu® - Zvu® HRAM Probe - DIVERSATEK HEALTHCARE, INC.

Duns Number:030650113

Device Description: Zvu® HRAM Probe

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More Product Details

Catalog Number

HRAM-200

Brand Name

Zvu®

Version/Model Number

HRAM-200

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

0fac9dcd-fa17-4f65-b2f9-43e174f8c225

Public Version Date

November 09, 2020

Public Version Number

1

DI Record Publish Date

October 30, 2020

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