Catalog Number

-

Brand Name

ThermoFlo®

Version/Model Number

6061

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"

Yes

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

BYD

Product Code Name

Condenser, Heat And Moisture (Artificial Nose)

Public Device Record Key

1bfbbd1e-b681-49e5-a9dc-c3b26d1fa899

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

July 21, 2021

Package DI Number

10810050853764

Quantity per Package

100

Contains DI Package

00810050853767

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case