NA - CO2 / O2 Oral-Nasal Cannula - Adult - Philips Medizin Systeme Böblingen GmbH

Duns Number:314101143

Device Description: CO2 / O2 Oral-Nasal Cannula - Adult

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More Product Details

Catalog Number

989803144501

Brand Name

NA

Version/Model Number

CO2 / O2 Oral-Nasal Cannula - Adult

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

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

MHX

Product Code Name

MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Device Record Status

Public Device Record Key

5220946b-7dfb-4762-aefa-e23cd7c28b4d

Public Version Date

August 15, 2022

Public Version Number

8

DI Record Publish Date

November 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 209