NA - Philips Medizin Systeme Böblingen GmbH

Duns Number:314101143

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More Product Details

Catalog Number

989803105681

Brand Name

NA

Version/Model Number

989803105681

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K001725

Product Code Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

9f8e6df4-b8f1-4ac3-a57d-de850f091273

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 23, 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