Catalog Number

684230

Brand Name

TC-PHY NICOY INTFC CA PHYSIOGARD

Version/Model Number

684230

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

aee8f592-2e98-4920-b39a-77d8bd8ecc2d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

50886333642309

Quantity per Package

1

Contains DI Package

00886333642304

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Zip Bag