HME Filter - Heat Moisture Exchanger, O2 configuration - EXCELERON MEDICAL, INC.

Duns Number:825179992

Device Description: Heat Moisture Exchanger, O2 configuration

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More Product Details

Catalog Number

-

Brand Name

HME Filter

Version/Model Number

HME-T-O2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

BYD

Product Code Name

Condenser, Heat And Moisture (Artificial Nose)

Device Record Status

Public Device Record Key

813c9f3a-5446-41fd-ad61-68504a48a1ed

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

July 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EXCELERON MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 1