FilterLine/Microstream - Philips Medical Systems Hsg

Duns Number:790605856

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More Product Details

Catalog Number

989803105561

Brand Name

FilterLine/Microstream

Version/Model Number

FilterLine H Set Infant/Neonatal

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

0531638a-bb60-4d1b-bb7e-77b1e6f3c812

Public Version Date

October 14, 2022

Public Version Number

8

DI Record Publish Date

December 20, 2016

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