O2-Sensor - IT Dr. Gambert GmbH

Duns Number:315273537

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More Product Details

Catalog Number

410040

Brand Name

O2-Sensor

Version/Model Number

MLF-60HC

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

-

Product Code Details

Product Code

CCL

Product Code Name

Analyzer, Gas, Oxygen, Gaseous-Phase

Device Record Status

Public Device Record Key

c4d8a704-9889-41aa-b26a-81376eb6c1af

Public Version Date

September 15, 2021

Public Version Number

1

DI Record Publish Date

September 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IT DR. GAMBERT GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 90