Duns Number:007941230
Device Description: 6 Lead Set Disposable 0.9M PVC PA66 Cream 10ea per box with 20 boxes per case GE ApexPro F 6 Lead Set Disposable 0.9M PVC PA66 Cream 10ea per box with 20 boxes per case GE ApexPro FH Comp Direct Connect Not made with natural rubber latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
DCL40004
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142489,K142489,K142489
Product Code
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
2e995d3e-b473-47e8-9e8f-c33d02692d0d
Public Version Date
June 18, 2021
Public Version Number
1
DI Record Publish Date
June 10, 2021
Package DI Number
20885632349673
Quantity per Package
20
Contains DI Package
30885632349670
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |