Duns Number:796452311
Device Description: DISP ECG LW,5LD,PINCH TO MULTI,INTERMED
Catalog Number
18601
Brand Name
DISP ECG LW,5LD,PINCH TO MULTI,INTERMED
Version/Model Number
DLW-05BM-40AM-3000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 28, 2017
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"
-
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
DSA
Product Code Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Public Device Record Key
0e0b95c8-632c-4b9c-b740-4161d8277c3e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
90840828101427
Quantity per Package
2
Contains DI Package
90840828101014
Package Discontinue Date
December 28, 2017
Package Status
Not 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 | 478 |
2 | A medical device with a moderate to high risk that requires special controls. | 8062 |