Duns Number:126290993
Device Description: 2 electrode arrays, Disposable Quick Connect Slim Cups with extension cable [14 pack]
Catalog Number
-
Brand Name
Rhythmlink®
Version/Model Number
MRQS2070715
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
3b58ba67-7051-4d94-9cc9-76e9ccca64d9
Public Version Date
June 27, 2022
Public Version Number
2
DI Record Publish Date
August 06, 2021
Package DI Number
10816312025948
Quantity per Package
2
Contains DI Package
00816312025941
Package Discontinue Date
June 24, 2022
Package Status
Not in Commercial Distribution
Package Type
Product Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 453 |