PHILIPS IntelliVue Temperature Parameter Module - Temperature Parameter Module for use with - Philips Medizin Systeme Böblingen GmbH

Duns Number:314101143

Device Description: Temperature Parameter Module for use with IntelliVue Patient Monitors MP40-MP90 and MX500- Temperature Parameter Module for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. The Temperature Module provides continuous body temperature readings at a variety of sites including skin, rectal, nasal, esophageal, arterial, and venous.

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More Product Details

Catalog Number

862291

Brand Name

PHILIPS IntelliVue Temperature Parameter Module

Version/Model Number

Temperature Parameter Module

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"

-

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

FLL

Product Code Name

Thermometer, electronic, clinical

Device Record Status

Public Device Record Key

e8699f8e-d618-4345-8b6f-37cc287d15b2

Public Version Date

August 15, 2022

Public Version Number

6

DI Record Publish Date

November 22, 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