Duns Number:595138793
Device Description: BATH PROBE CABLE with cable length 96". It has a 4-pin monitor connector.
Catalog Number
684072
Brand Name
BATH PROBE CABLE -SP5030
Version/Model Number
684072
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
-
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
DXG
Product Code Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Public Device Record Key
98c16bad-2eec-477f-a55e-fa7449f0f436
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 25, 2016
Package DI Number
50886333640725
Quantity per Package
1
Contains DI Package
00886333640720
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Zip bag
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 392 |