Duns Number:529691989
Device Description: Mindray Pano-Philips 3L ECG Adapter
Catalog Number
-
Brand Name
Mindray
Version/Model Number
A-CO-182
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
-
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
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
0a3fe637-f84e-479a-8f4a-25572346c064
Public Version Date
November 03, 2021
Public Version Number
3
DI Record Publish Date
May 28, 2021
Package DI Number
16946725590635
Quantity per Package
25
Contains DI Package
06946725529034
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 475 |