Catalog Number

M300-5

Brand Name

Cardea SOLO

Version/Model Number

M300-5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

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

K162503,K162503

Product Code

DQK

Product Code Name

Computer, Diagnostic, Programmable

Public Device Record Key

e9743a53-be40-4cc1-a912-9a5c2f05afd7

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

July 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-