Catalog Number

MHD8C503

Brand Name

FLOTRAC, TRUWAVE

Version/Model Number

MHD8C503

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

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

K131588,K131892,K152980,K131588,K131892,K152980

Product Code

DQE

Product Code Name

CATHETER, OXIMETER, FIBEROPTIC

Public Device Record Key

5e622ba8-b7d4-4287-aba7-3bb2d69604bb

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 03, 2016

Package DI Number

50690103194758

Quantity per Package

5

Contains DI Package

00690103194753

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper