Duns Number:790605856
Device Description: Disposable radiolucent foam electrode for use with X-ray procedures. Silver/silver-chlorid Disposable radiolucent foam electrode for use with X-ray procedures. Silver/silver-chloride (Ag/AgCI)sensor, non-metallic snap, pre-gelled; Oval shape, 43mm x 36mm size; 30 per pack, 600 electrodes per case; Shelf life; at least 6 months; Can be used with all Philips Adult ECG Monitors. Only available in Japan
Catalog Number
989803148821
Brand Name
ECG Electrodes
Version/Model Number
ADULT RADIOLUCENT ELECTRODE (FOAM)
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
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
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
9b634a1a-d8e8-4522-ba5b-9fb084298337
Public Version Date
January 11, 2022
Public Version Number
6
DI Record Publish Date
December 26, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |