Catalog Number

-

Brand Name

InHealth Technologies; Blom-Singer

Version/Model Number

PK 2105

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

BYD

Product Code Name

Condenser, Heat And Moisture (Artificial Nose)

Public Device Record Key

e647cd43-6d44-4a00-bec5-36f1f3f06459

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

June 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-