Duns Number:007941230
Device Description: Leadset Ecg Universal Cam 14 Single 40 Inch Ge Compatible Reusable Not Made With Natural R Leadset Ecg Universal Cam 14 Single 40 Inch Ge Compatible Reusable Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
CL8408
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
31ca3762-bdb3-4d4a-83e9-aef11c2247fe
Public Version Date
September 07, 2018
Public Version Number
3
DI Record Publish Date
August 20, 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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |