NA - Philips Medical Systems Hsg

Duns Number:790605856

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More Product Details

Catalog Number

989803106971

Brand Name

NA

Version/Model Number

989803106971

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

K031187

Product Code Details

Product Code

MKJ

Product Code Name

Automated external defibrillators (non-wearable)

Device Record Status

Public Device Record Key

4d887e1e-98a5-4370-88b5-79fb8bb05beb

Public Version Date

November 24, 2021

Public Version Number

4

DI Record Publish Date

January 24, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS MEDICAL SYSTEMS HSG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 323
3 A medical device with high risk that requires premarket approval 36
U Unclassified 1