NA - PICCO Temperature Probe - Philips Medizin Systeme Böblingen GmbH

Duns Number:314101143

Device Description: PICCO Temperature Probe

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More Product Details

Catalog Number

989803110861

Brand Name

NA

Version/Model Number

PICCO Temperature Probe

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)

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

DRT

Product Code Name

MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

Device Record Status

Public Device Record Key

18854d8d-1781-4493-874e-820f543c72b7

Public Version Date

August 11, 2022

Public Version Number

6

DI Record Publish Date

January 19, 2017

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