HME without Gas Sampling Port; Straight - Medicomp

Duns Number:154454730

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More Product Details

Catalog Number

MC-751NF

Brand Name

HME without Gas Sampling Port; Straight

Version/Model Number

MC-751NF

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

51bb706f-d0ac-42f7-8d0d-d25cff9edd42

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 11, 2017

Additional Identifiers

Package DI Number

10858409005136

Quantity per Package

50

Contains DI Package

00858409005139

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"MEDICOMP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 53
2 A medical device with a moderate to high risk that requires special controls. 5