Catalog Number

FVMA0051

Brand Name

Flying-V cuff SMALL

Version/Model Number

G2.1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 10, 2021

Issuing Agency

In GS1

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

K014063

Product Code

DSB

Product Code Name

Plethysmograph, Impedance

Public Device Record Key

5dededbe-3fad-4a47-9cb1-2cefeec98279

Public Version Date

November 10, 2021

Public Version Number

7

DI Record Publish Date

November 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-