Duns Number:070556204
Device Description: Curaplex Select Defib Pads, Physio Adult Combo, Leads Out Direct Connect 10pr/cs
Catalog Number
-
Brand Name
Curaplex
Version/Model Number
16242
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"
Yes
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
K080421,K080421
Product Code
MLN
Product Code Name
Electrode, electrodcardiograph, multi-function
Public Device Record Key
632b1edd-d508-457f-ac74-6d5b7af6d899
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 14, 2016
Package DI Number
00815277023801
Quantity per Package
10
Contains DI Package
00815277023795
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |