Catalog Number

00055

Brand Name

Flying-V - finger cuff (medium)

Version/Model Number

G2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 19, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K014063

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

c04b98b1-bce3-45e9-bdaa-2b108fc9fddc

Public Version Date

November 20, 2019

Public Version Number

4

DI Record Publish Date

October 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-