NA - 5 Lead Snap Chest AAMI, ICU - Philips Medizin Systeme Böblingen GmbH

Duns Number:314101143

Device Description: 5 Lead Snap Chest AAMI, ICU

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

989803144911

Brand Name

NA

Version/Model Number

CBL 5 Lead Snap Chest AAMI, ICU

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

IKD

Product Code Name

CABLE, ELECTRODE

Device Record Status

Public Device Record Key

98e8b23f-f837-4494-a2f3-369285226b76

Public Version Date

June 08, 2022

Public Version Number

5

DI Record Publish Date

November 30, 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