Duns Number:100439103
Device Description: ECG Cable, 5-Lead, Grabbers, Single Patient Use, 85cm
Catalog Number
-
Brand Name
Philips
Version/Model Number
RM-989803172031
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
0bddbba0-2315-41f2-ac96-a39d3b884102
Public Version Date
July 19, 2022
Public Version Number
1
DI Record Publish Date
July 11, 2022
Package DI Number
10816317024014
Quantity per Package
20
Contains DI Package
00816317024017
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 68 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |