TEC - TEC 850 ISO - DATEX-OHMEDA INC

Duns Number:129501685

Device Description: TEC 850 ISO

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More Product Details

Catalog Number

-

Brand Name

TEC

Version/Model Number

850 ISO

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K172702

Product Code Details

Product Code

CAD

Product Code Name

VAPORIZER, ANESTHESIA, NON-HEATED

Device Record Status

Public Device Record Key

5af13ad3-4e14-4719-b3e0-8537e43e22d4

Public Version Date

May 12, 2022

Public Version Number

3

DI Record Publish Date

March 12, 2018

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