OxyPlus™ - OxyPlus ETCO2, 7ft oxygen tubing, 8in sampling - Southmedic Incorporated

Duns Number:246848147

Device Description: OxyPlus ETCO2, 7ft oxygen tubing, 8in sampling line with female connector ETTI

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More Product Details

Catalog Number

OP-2325-8

Brand Name

OxyPlus™

Version/Model Number

OP-2325-8

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 18, 2020

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

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Device Record Status

Public Device Record Key

3deb78d1-5abd-41f6-97a4-ccde1c089bf9

Public Version Date

December 18, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOUTHMEDIC INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 91
2 A medical device with a moderate to high risk that requires special controls. 18
3 A medical device with high risk that requires premarket approval 2