TEC 6 PLUS - DATEX-OHMEDA INC

Duns Number:129501685

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More Product Details

Catalog Number

-

Brand Name

TEC 6 PLUS

Version/Model Number

VAP DES 120V USA

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

-

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

K000275

Product Code Details

Product Code

CAD

Product Code Name

VAPORIZER, ANESTHESIA, NON-HEATED

Device Record Status

Public Device Record Key

d1afb374-0616-4bd1-961b-5db2c45a9fd2

Public Version Date

October 25, 2019

Public Version Number

4

DI Record Publish Date

June 01, 2016

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