Duns Number:796452311
Device Description: DLW,3LD, SNAP,INTELLIVUE,"XX",AHA
Catalog Number
18130
Brand Name
DLW,3LD, SNAP,INTELLIVUE,"XX",AHA
Version/Model Number
DLW-03AK-40AS-0000
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"
-
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
d7d18786-50aa-4519-a1ef-b8c0a0a0411b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
90840828100642
Quantity per Package
10
Contains DI Package
90840828100628
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 | 478 |
2 | A medical device with a moderate to high risk that requires special controls. | 8062 |