Catalog Number

21-FHCN-15544

Brand Name

CNAP® Monitor 500 HD

Version/Model Number

V1.5

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

-

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

K183521

Product Code

DXG

Product Code Name

Computer, Diagnostic, Pre-Programmed, Single-Function

Public Device Record Key

a9cb4ea9-b45f-456a-816c-d8c843c91f96

Public Version Date

October 23, 2019

Public Version Number

1

DI Record Publish Date

October 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-