Avance - AVANCE CS2 - DATEX-OHMEDA INC

Duns Number:129501685

Device Description: AVANCE CS2

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More Product Details

Catalog Number

-

Brand Name

Avance

Version/Model Number

CS2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K123125,K131945,K172045

Product Code Details

Product Code

BSZ

Product Code Name

Gas-machine, anesthesia

Device Record Status

Public Device Record Key

c3604119-4326-4e8d-a116-d7f9d0563614

Public Version Date

May 12, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DATEX-OHMEDA INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 73
3 A medical device with high risk that requires premarket approval 1