ECG Electrodes - 3-Lead Set, disposable, for single patient use, - Philips Medical Systems Hsg

Duns Number:790605856

Device Description: 3-Lead Set, disposable, for single patient use, to measure bedside ECG. IEC color coded gr 3-Lead Set, disposable, for single patient use, to measure bedside ECG. IEC color coded grabbers. Round (rd) peelale ribbon style wires. Wire length: 3,3ft (1m). For use with trunk cables: M1668A,M1669A, 1 Sales Unit = 20 single wrapped lead sets

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More Product Details

Catalog Number

989803174201

Brand Name

ECG Electrodes

Version/Model Number

3 LEADS SET DISPOSABLE, BEDSIDE IEC RD

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)

-

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

DSA

Product Code Name

CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Device Record Status

Public Device Record Key

c9789af1-a4fe-4c6d-8636-62417c3216e1

Public Version Date

September 27, 2022

Public Version Number

8

DI Record Publish Date

November 21, 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