Resp-O2 EtCO2 Nasal Sampling Cannula - Resp-O2 EtCO2 Nasal Sampling Cannula 7' (2.1m) - DYNAREX CORPORATION

Duns Number:008124539

Device Description: Resp-O2 EtCO2 Nasal Sampling Cannula 7' (2.1m) Tubing, Male Luer Connector Adult, Standard Resp-O2 EtCO2 Nasal Sampling Cannula 7' (2.1m) Tubing, Male Luer Connector Adult, Standard O2 Tubing Connector

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More Product Details

Catalog Number

-

Brand Name

Resp-O2 EtCO2 Nasal Sampling Cannula

Version/Model Number

33182

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K143150,K143150

Product Code Details

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Device Record Status

Public Device Record Key

1d6bb03c-9766-49d6-8187-4d5bfc4bbb01

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

April 22, 2021

Additional Identifiers

Package DI Number

00840117316508

Quantity per Package

25

Contains DI Package

00840117316591

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2